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FDA Inspection Stories

  • 1.  FDA Inspection Stories

    Posted 25-Aug-2016 13:13

    Hello All -

    I am presenting in a couple of weeks on FDA authority in inspections. I am looking for any examples, but the particularly egregious ones, where the "reasonableness" standard for FDA inspections was crossed. In my own experience I've seen pulling files off desks, opening filing cabinets without permission (cabinets held personnel material), yelling/threats, demands to sit in production areas, and handling product ready for shipment without gloves.

    My presentation will focus on what is clearly reasonable, access to all production lines, access during normal business hours, and contrast with egregious behavior to cover a spectrum of the "reasonableness standard" for FDA warrantless inspections. 

    Any example or stories you care to share?

    Many thanks!

    Marc

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States
    ------------------------------


  • 2.  RE: FDA Inspection Stories

    Posted 26-Aug-2016 10:07

    Interesting topic Mark,

    I don't have anything recent - my recent inspections have all been conducted very openly and fairly.Even the one that resulted in a WL for the company, I thought the inspector was amazingly fair - that was all on the company not getting things fixed quickly enough.

    However, back 20 years ago, we had an inspector spy some "liquid paper" on the desk of our office manager. He asserted that medical device companies should not have this anywhere in the building, and proceeded to spend about 2 weeks looking at every document in our doc control file cabinets (yes, paper based system back then) trying to find some "white out" on a controlled document or record. He didn't find any, but I always thought that was a bit of an overreach.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 3.  RE: FDA Inspection Stories

    Posted 28-Aug-2016 03:52

    Well, there is always the distinct possibility that he decided to look for liquid paper on all your documents because he didn't feel qualified to assess anything of a more technical nature.

    Twenty years ago would have been about the time I heard a former FDA inspector talk about his earliest inspections.  He said his favorite finding was that the company didn't have something they were supposed to have, because that was an easy write-up.   If they had what they were supposed to have, then it was, "Well sh*t, now I have to figure out whether what they have is in compliance."

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 4.  RE: FDA Inspection Stories

    Posted 26-Aug-2016 11:35

    Going through garbage cans on site of facility.

    ------------------------------
    Jonathan Kovach
    Vice President, QA/RA
    Spacelabs Healthcare, Inc.
    Sammamish WA
    United States



  • 5.  RE: FDA Inspection Stories

    Posted 26-Aug-2016 12:06

    Ah ha, they must have learned that one from Mylan Labs. :)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 6.  RE: FDA Inspection Stories

    Posted 26-Aug-2016 12:03

    I work mostly in premarket, so my personal experience is limited. That said, everyone in the industry, and especially people in RA, share their experiences.  When I started in the early 90s, I did hear occasional reports of this type of behavior, but mostly those stories were from the 80s, and...if it's not in writing, it didn't happen....they were rumors.

    I have not heard any such stories in a long time, which isn't to say I don't think this ever happens today.  One of the first lessons I was taught when I started in regulated industry is that "FDA is not a monolith."  This is individual behavior, not agency behavior. 

    If it is an inspection team that is exhibiting this behavior, that's a big problem.  If it is one person, that's something else entirely.  Oddly, FDA hires people, just like industry does.  And, in the industry, I have worked with and for people who had drinking problems, bipolar disorder, etc, and the public remains largely ignorant on the effect blood sugar can have on the behavior of some people. 

    I think it would be more helpful to focus on how to handle this situation.  Personally, I would first inform everyone in the company that this inspector seems to have a problem, that this is not typical FDA behavior, and that anyone dealing with this inspector should be as cooperative and remain as calm as possible.  Then I would call someone at FDA with whom I had a good relationship, explain the situation, and hope they might be able to quietly intercede to have the inspection cut short.  This person probably needs help, and the sooner, the better.

    Otherwise, just another weird day at the office.  How an inspector behaves, short of posing a safety risk to company employees, is less important to me as an RA professional than how it plays out in terms of a 483 or WL, because those DO represent agency behavior.  If the person has a problem, it's unlikely to be unknown by anyone at the agency, and I would expect a reasonable response to any of this person's findings to be quietly accepted and quietly filed away.  If not, maybe that's when you call the lawyers.

    I would be interested to know if one could legally and surreptitiously video an inspector's behavior with a smartphone.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 7.  RE: FDA Inspection Stories

    Posted 27-Aug-2016 14:36

    I agree with Julie.  In 33 years, I have too many stories to tell.  Most investigators are decent people but they are typically, by nature, a group skeptical of industry behavior and that can drive them to some odd choices/positions in inspections.  The key as Julie said is to have an inspection SOP document that you train the organization and on and it can be referred to in an inspection.  We speak lots on this topic and one of our lawyers is a former FDA investigator (4 yrs. LA, 7 yrs. MPLS.).  And be prepared to seek counsel if someone is out of bounds.  Don't let it go too far before you try to rein them in.  It is a balance knowing what to let go and what to push back on and every investigator/situation is different.  Again. it is best to be proactive and to know your rights from the statute and regulations especially because FDA is taught in its Inspections Operation Manual (IOM) to be aggressive and even ask for things to which they may not be entitled because if the manufacturer gives it to the Agency it is deemed consent.  So know what records they are and are not entitled to; anticipate attempts to take photographs; anticipate them trying to gain information by talking to people other than those assigned to lead and host the audit; Expect them to request interviews which they cannot do; expect them to ask you to sign affidavits; expect them to request advertising and promotional records (especially if your company has made those records part of the quality system); expect them to request BIMO records and on and on….we've seen it all, but patterns emerge and there are plenty of interesting outliers.  You may have to go over an investigator's head in real time to speak to the head of Compliance within your District, the District Director and in some cases Compliance within the Center in Silver Spring, Md.  We've gotten investigators (or their superiors at least) to back down from many things…

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

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  • 8.  RE: FDA Inspection Stories

    Posted 26-Aug-2016 12:53

    Thank you for the replies!



    Ginger - I never thought that white-out could lead to such panic!!

    I agree Julie. At the end of the day the agents are people with good days and bad and subject to the same work burn-out any of us face. I typically work with the District to report egregious behavior for clients. The most common response is to pair the inspector with a buddy. In one cases my report was the final straw amid many similar complaints.



    I don't see why you couldn't openly video the inspector. It is still the facility owner's right and they are not stopping the inspection. The warrantless inspection merely means the inspector is allowed in to search.



    The reasonableness question doesn't get litigated - we'd rather avoid making enemies in a district and when the FDA can obtain a warrant why ask for it. Still as drones take to the air and smart phones carry personal and business data it is a matter of time before a standard developed in the 1950s (what smartphone!) and tested in court with other Agencies around that era are tested. It will be interesting!

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States



  • 9.  RE: FDA Inspection Stories

    Posted 27-Aug-2016 17:58
    Marc,

    There are three groups of people, generally speaking at FDA.

    1. - people who understand the industry
    2. - people who don't trust industry due to lack of adequate, relevant industry experience
    3. - those who don't want to trust the industry regardless

    The term "reasonableness" should be interpreted as applicable to both parties.

    Per 21 USC 374(a)(1)(B), "at reasonable times" within reasonable limits and in a reasonable manner...."

    I've seen in several cases that it was corporate lawyers who failed to provide adequate training to the employees. In a case, it was a corporate counsel who has driven employees to get overly defensive for GMP compliance matters.

    After FDA inspection, the lawyer accused FDA inspectors of not knowing anything about how to inspect or lack of experience in performing inspections, etc.

    In fact, it was this lawyer who caused me, in part, to launch my training and educational services to the global and FDA-regulated industry.  

    I'd like to see industry professionals and FDA inspectors rather exercise sound judgment with adequate awareness and reasonableness!  

    At the end of the day, if you are very familiar with subject matters, no reason to be unreasonable!  Real professionals choose to be reasonable! 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 10.  RE: FDA Inspection Stories

    Posted 27-Aug-2016 18:07
    Marc,

    The point that I was trying to make, the point of which should be penetrated into professionals, is that it is important to make inspectors feel OK at all times. If they feel corporate employees are unnecessarily defensive, they may choose to go "wild."

    Let's keep our emotion and professionalism unbiased and under check at all times.

    In fact, I have provided FDA GMP trainings many times over the years. I also have performed critical analysis of what triggers professionals to behave the way they do under the situated circumstances. 

    David





  • 11.  RE: FDA Inspection Stories

    Posted 28-Aug-2016 12:14

    I agree with you also David.  That is why we have co-hosted programs in Minneapolis for the last decade with the local Minneapolis FDA District Office and why I speak around the country with FDA on inspectional matters, i.e. OCRA, Xavier, RAPS Atlanta, etc.).  We develop strong relationships with the Districts and the Center and get good results.  Like I said in my last post they are decent people, trying to do their job.  As I also said you need to focus on the majors, not the minors, as you go along in your inspection.  But never feel bad politely but firmly asserting your rights, they usually are very accommodating.  And like Julie said you will always get outliers (like in industry) who sometimes, with FDA management's help, need to be reined in.  We, like you, are completely focused on FDA, not corporate matters.  I'm sure you would agree David that working with FDA this is not an area to dabble in.  

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

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    PLEASE NOTE:  The information contained in this message privileged and confidential, and is intended only for the use of the individual named above and others who have been specifically authorized to receive it. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, or if any problems occur with transmission, please contact sender or call 612.338.7170. Thank you.

     

     






  • 12.  RE: FDA Inspection Stories

    Posted 28-Aug-2016 02:23

    Ok, so let me ask a stupid question. 

    Affidavits, I get.  But exactly what is/are the concern(s) about inspectors looking at stuff they aren't "supposed to" look at?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 13.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 09:01

    OK, so take a simple example.  The inspector asks to see your management review documents or audit documents.  Per the reg's we're not required to share them.  How do you politely say it's none of your #@#$@ business. OK, we wouldn't actually say that, but is it appropriate to tactfully point out that we're not required to share those documents?  How do you handle the "out of bounds" situation in an audit without creating the natural suspicion?

    ------------------------------
    Rick Muller RAC
    Technical Director
    Celestica Healthcare
    Aurora CO
    United States



  • 14.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 09:58

    Interestingly, a few years ago I had a 2-3 day running debate with an inspector on that very topic. He asked for our list of audit findings. I nicely said "hey, every FDA conference I go to says you don't have a right to ask for those." He said their view was they did. I said the preamble (to the QSR) says they won't. After talking to his boss, he cited a different section of the preamble to support asking for them. Now, understanding this was a very reasonable inspector, in the end we worked it out. I came up with a really simple list. He glanced at it and gave it back. And the only ones he really looked at were the ones I provided to show we already were working on something internally and thus get out of a 483 observation (yes, that worked).

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 15.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 10:24

    I agree David and Mark. The aim is to avoid situations where reasonableness is an issue and not to handle the inspection with suspicion. There are invariably situations where some request seems out of bound - from the simple taking photos in a facility to the complex like shouting. That is where this fuzzy question of reasonableness opens itself to interpretation. 

    Once consent is given there is no ability to later challenge whatever findings come from that permission. For me this is what makes the question interesting. As we get further from the Factory Inspection Amendments of the 40s or 50s and into more complex technology this issue may crop-up due disagreement on interpreting what is "reasonable." The FDA will nearly always take an expansive interpretation of the term, statute and case law from other administrative agencies whereas Industry likely takes a narrow interpretation. Natural conflict arises.

    To Julie and Ricks questions - the FDA could always obtain an administrative search warrant to obtain the information. Worse case scenario that warrant could be challenged. Often what I find is that most agents will discuss the issue and even open the discussion to the district office. I advise clients to not consent but not impede when in doubt - that is to not give consent in order to permit a later challenge as needed, but also not stop the inspection due to the risk of misdemeanor penalties. For the most part not a big issue, but I still come back to the idea that this could be an issue ripe for judicial challenge at some point in the near future.

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States



  • 16.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 11:30

    Ok, so here is a concern that has been expressed so far:

    "Once consent is given there is no ability to later challenge whatever findings come from that permission"

    I'm aware that an FDA inspector is not "supposed to" look at audit findings.  For me, this is more likely to mean clinical monitoring reports than manufacturing facility audit reports.  FDA confirmed publicly that this principle applies to monitoring reports in the wake of the QSR, but this was never really documented.  I have since inquired of BIMO, they confirmed again, and now I have that email on file.

    The rationale was that this would undermine the whole quality process, since auditors and monitors would be seriously restricted in their jobs.  "I can't document it, because FDA might see it."  Can't document it, not likely to be followed up on and resolved.  As far as I know, "FDA" was, and still is, on board with this perspective.  Whether "OC" is on board, I don't know. It is, after all, OC, not OQ, and C and Q tend to be mutually exclusive mindsets.

    If all of the above applies, then I don't see a need to challenge the findings.  I would be more likely to reach out to someone at FDA and ask, "hey, are you guys still on board with this or not?  Because if you are, then you need to do better at getting the word out to your inspectors, because I'm just not going to do it for you.  They want to see my monitoring reports, they are welcome to them,.  And then FDA inspectors are undermining the system that FDA says it wants, which means they are creating a problem for FDA, not for me."

    As for challenging the findings, I don't want to do that.  I want to address them.  Anything a monitor wrote in their report should have been followed up on.  If it was, then that's how I address it, by describing the follow-up and final resolution.  If it wasn't followed up on, then the finding, however come by, is legit. And so be it.

    Maybe I've seen one/a hundred too many episodes of L&O, but somehow all of this reminds me of trying to get the murder weapon excluded because the search was illegal.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 17.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 11:42

    Hang on for this reply-lets continue to help each other learn and gain perspective and insight.  Here's mine.

     

    You guys please don't take discussion too seriously, nor underestimate the importance of it.   The inspections we've been involved have never ended in a knock-down, drag-out fight.  I've been through hundreds of inspections, some of which we get involved in, others where we counsel behind the scenes.  When I do get involved I just set the expectations with the investigator if they get a bit off track and then things 95% of the time go swimmingly.  The issue is that we have experienced regulatory creep over the years and over time it begins to erode the industries rights. 

     

    It happens when we acquiesce to FDA's view of the world on not just inspectional matters, but also on definitional issues under the 510(k) program (i.e. what is same intended use, same technological characteristics, what are different questions of safety and effectiveness, what is a multiple predicate?); or when is a modification a letter-to-file versus a traditional 510(k), and on and on.  When industry comes to us to represent them, we sometimes have to remind FDA'ers in the field or in the Center what the statute, regs and often their own guidance documents (some of which are not rue to the statute or regs) say.  For example, FDA no longer applies the risk/benefit guidance to 510(k)s because we challenged it.  It now only applies to de novos and PMAs (although they are now revisiting the 510(k) world).  We challenged FDA's definition of what a "major change to the intended use" for a modification and won. 

     

    I've had investigators ask for executive committee and even Board minutes of reviews of inspections.  They've asked for financial records and sales information and to interview sales representatives.  Would you allow this sort of conduct?  Of course not.  They've tried to take pictures of a state of the art transdermal patch coating machine years ago that our competitors would have died to get their eyes on.  We've had FDA mistakenly release trade secret, confidential information under FOIA to competitors and apologize for it, but the damage was done.  Much of this we've brought this on as an industry because we acquiesce to too much.  In the pharma world, which has the same statute, they don't acquiesce to many of the things medical device reggers do.  It's not a criticism, some of it is ok, but it is a fact.

     

    Remember delivering safe product is joint responsibility of ours and FDA's, but FDA inspects us after the fact, they don't do it for us.  And they like to crawl onto your quality team to be prescriptive about how you do things.  Remember in the Utah Medical case the judge rebuffed an aggressive FDA District Office who stated the company out of compliance, but the company was just doing quality in a different, but safe way.  The judge eventually told FDA, to paraphrase, "there are many roads to Rome" meaning FDA don't be so prescriptive about quality, rather confine yourself to the question of whether they are putting out safe product.  We all, for the most part, like where things have evolved from a quality perspective and FDA is our partner, a valued one at that.  But we must be careful they we don't allow them to start telling us how to do our jobs in great detail.  We are at the front lines of safety for patients, not FDA. 

     

    What I mean to say is we don't fight FDA on too much, we push back on others, and mostly we just cooperate like you folks do.  We want to avoid getting a "refusal to inspect."  We've never had that happen.  Unfortunately we sometimes cooperate for expediency sake, everyone does, and FDA's expectations of what they can do gets shaped but what we accept.  No one wants this process to be confrontational and rarely is it.  But we need to be vigilant in understanding what our rights are so we know what we are giving up.  We must be careful over time that we do not unnecessarily or unwittingly expand FDA's jurisdiction and authority.  I wish I could share the many, many stories I have that would curl your hair, but I can't because they are attorney-client privileged.  I was general counsel of 3M Pharma, 3M Drug Delivery systems and three 3M medical device divisions (with a year in Europe) before becoming Medtronic's head FDA lawyer for a while.  We've had 750 clients in 13 years and believe me, we've seen it all…one of our lawyers was an FDA investigator for 11 years and he will tell you not all investigators are alike and some have personal agendas and like pushing the envelope and some even like to confront.  So let's keep our antennae up.   

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

    facebook icontwitter iconlinkedin icon

     

     

    PLEASE NOTE:  The information contained in this message privileged and confidential, and is intended only for the use of the individual named above and others who have been specifically authorized to receive it. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, or if any problems occur with transmission, please contact sender or call 612.338.7170. Thank you.

     

     






  • 18.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 01:55

    “we acquiesce too much.”

    I think that, for me, this is probably the crux of the matter.

    Who are “we”? I’m a regulatory affairs professional, not a lobbyist. My focus is not on industry, but on individual companies. All of my decisions about how to deal with FDA, whether to push back or acquiesce, are intended to serve the best interests of my employer or client, not those of the industry. That, I leave to the lobbyists.

    Too much for what? And for whom? For me the answer is, again, “for the best interests of my employer or client.” Who decides how much is too much, too little, just right? Ideally, it’s the executive team, and, ideally, their decisions are intended to serve the best interests of the shareholders, not the industry.

    I think it's a difference in yardsticks..."too little, too much, just right" measured against what the law allows, versus what best serves the company.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 19.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 13:18
    I think the other key is that you have to get a "read" on the inspector. I tend to handle one being a jerk very differently than I handle one who is reasonable and professional. Just like in other parts of business.

    g-





  • 20.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 14:01

    This has been an interesting string to read.  As an ex-FDA Investigator and now with more than 40 years in the industry, I have found there's plenty of similarities on both sides.  Good, bad, friendly, unfriendly, smart, not smart, helpful, not helpful, defensive, not defensive, etc.  As has been pointed out, the objective of an FDA audit is just that … it's an audit.  They are regulators and there to enforce the regulations.  Although they may not have legal authority to "demand" certain information, they can always ask.  And, to address your question Julie, while if there is really no reason not to share an answer rather than saying "no," I can envision times the answer may lead down a path you'd rather not go.  Thus, you may say no.   I've always found transparency, whenever possible, is a much better route to take.  Chris

     

    Christopher Smith, CQE, RAC

    President, Coastal Pharmaceutical Consultants, Inc. ®

    7950 Old River Road, Burgaw, NC 28425 USA

    910-259-8877 (land)

    910-789-1232 (mobile)

    chrissmith@coastalpharmaconsultants.com

     






  • 21.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 15:53

    I agree that we should always be professional in our relations with FDA inspectors. But remember that this person is investigating the possibility that your company is  in violation of a Federal Law. Or to put it another way, he/she is looking at a potential crime scene. If there is an item in an inspector's request list that is not one he is specifically allowed to obtain, you have a duty to your company to question that request.  If the company has a policy of complete transparency, then of course you can go right ahead. As a matter of fact, it makes sense to have a section of your inspection SOP specifically for unexpected Inspector's requests. After all, the regulations says you don't have to give it to him/her, not that he/she can't request it. 

    The regulation at 820.180(c) specifically exempts management reports and quality audit reports from the requirement to have required records readily available  for review and copying at the request of an FDA inspector. This exemption is limited to routine inspections  It clearly indicates that you must have some evidence that the audits were performed and reviewed and acted upon by management, and suggests a signed statement by the relevant management person, that the quality audits were performed on (date) by (vendor) and reviewed by (management) on (date), and resulted in (number 0 to n) corrective actions.

    Ginnie's response was perfect. She politely questioned the inspector's request, went up the ladder to the inspector's boss, and ended up with with something more like what the regs says she must provide.

    An historical note: this reg came in in the 96 regulations-before that there was only a statement of the same policy for  quality audit reports in the preamble to the 78 regs. There are explanations of the exception for quality audits in the preamble of the 96 regulation, too, but the regulation is pretty clear.

       

    ------------------------------
    Anna Longwell MS, JD RAC
    Principal
    Longwell and Associates
    Palo Alto CA
    United States



  • 22.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 23:53

    I agree that the best way to handle this is in advance, in corporate policy and inspection SOPs, because the important discussion here is the one between RA and executive management, not between RA and the FDA inspector.  It is my duty to question a request if and only if executive management says it is my duty.  Otherwise, it's not my duty; it's my call.  Like Ginger, I would probably question it, because I would want to know.

    But fundamentally, I don't much care what FDA looks at.  Whatever they find, it's my job to address it, and that doesn't change based on whether they found it in something they were or were not supposed to look at.  The more they look at, yes, statistically speaking, the more they are likely to find, but again, that's the job.  I do it because I like it, so it would be kind of weird for me to deeply resent having to do more of it.

    More important, if FDA finds something legit, it's the finding I'm really concerned about, not FDA. It means we not only screwed up, but we screwed up again when our QS didn't prevent it, and yet again when our internal QA didn't catch it.  The way I see it, that's a triple failure on our part and a lot bigger problem for the company than anything the FDA is likely to do about it.  I'm certainly not happy that FDA was the one to find it, but since pretty much any legitimate finding represents a potential risk to patients, somebody needed to.  And, most of the time, whatever we need to do to address it with FDA is what we need to do, FDA or no FDA.

    On the other hand, if the finding is not legit, then that's a PITA, but PITAs happen, and the job remains the same.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 23.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 11:20

    Now MDSAP ? … this is a great string; especially about what FDA asks vs what they are allowed (by regs) to audit.
    So … thinking ahead…what are the thoughts on MDSAP? Please help but so far the scenario that I keep hearing is … If you have Canada/CMDCAS audits now, very soon you'll get Health Canada audits via the MDSAP program. MDSAP reports automatically go to the FDA, so now FDA (and the MDSAP auditors) will see all, even what is not allowed by the US regs. And your competitors will see all because what FDA has, is available under US FOIA requests.

    Art

    PS FDA inspection is a law enforcement activity (vs ISO and CE inspections that are licensing/certification activities). Both may look the same, and some may say they are the same, but they are very different … the cop with the radar detector vs the cop observing you during your driving test. Just FYI … I look to be the same cop, on Saturday mornings, giving drivers ed; preparing folks to avoid trouble in the test and from the radar.

     

     






  • 24.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 09:38

    We've been working with our Congressional delegation to address how FDA (and other government agencies0 are using international harmonization efforts to get around U.S. law and accomplish things they want to do indirectly that they cannot do directly in a wide variety of areas such as inspections, etc.  Congressman Paulsen co-chairs the House Caucus on Medical Technology and Senator Klobuchar co-chairs the Senate version-both from Minnesota. This is a real issue and you've just pointed out another example. 

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

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  • 25.  RE: FDA Inspection Stories

    Posted 18-Sep-2016 00:50

    I wasn't aware that the MDSAP program would make information available that isn't allowed under US regs.  Which information is that?  And which regs?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 26.  RE: FDA Inspection Stories

    Posted 19-Sep-2016 07:57

    Hi Julie,   A couple of weeks ago I attended a RAPS workshop (Bridgewater, NJ) on MDSAP.  The instructor said MDSAP will allow FDA to see 1) internal audits, 2) management reviews and 3) corrective actions.

     

    Matthew Marton, PhD, RAC
    Director, Genomics & Companion Diagnostics

    Merck Research Laboratories | 126 E. Lincoln Avenue Rahway, NJ 07065
    office: (732) 594-1945 | cell: (206) 384-1486 |
    matthew_marton@merck.com

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  • 27.  RE: FDA Inspection Stories

    Posted 19-Sep-2016 10:29

    That's very interesting. 

    I've been focused on the implications in the EU, where it seems that MDSAP means the entire world will now be able to see everything about their audits, where in the past they weren't able to see anything, not even if an audit had occurred.  I hadn't given much thought to the impact in the US, because the US already has a lot of transparency.

    What FDA can see, the public can see, at least in summary, and what FDA can't see, the public can have no knowledge of.  I think the regulatory agencies in other jurisdictions have been able to look at things FDA can't, because what other agencies find usually stays between the agency and the company.

    This would seem to be an example of being careful what you wish for.  The industry has been lobbying aggressively for harmonization for decades, and now it looks like it might just get it.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 28.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 12:31
    Julie,

    "...It means we not only screwed up, but we screwed up again when our QS didn't prevent it, and yet again when our internal QA didn't catch it..."

    In my practice, what I frequently observe is rather easier to identify non-conformity and/or inadequacy in quality manuals/SOPs than firms' willingness to adequately implement the policy, plan, SOPs, etc. 

    For such firms, they learn by screwing things over and over - an easy way to go and learn at the relevant time, but hard/painful way to learn for a long term. 

    What may trigger behind, in large extent, is lack of trust and belief, leading to lack of motivation and stress.  In fact, "Trust and Belief Really Matters" in business process and GMP matters!

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 29.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 12:09

    Julie, you seem to be dealing mostly with BIMO and pre-PMA inspections, which do NOT have the legal exception described in the reg, which is for routine QSR inspections only. In my years of supervising regulatory departments, the unquestioning compliance by a subordinate to a request by an inspector which seems to him/her to be contrary to current FDA regulation, would be a matter for that person's personnel file,and a re-training session or two. You were smart to get a letter. However, the letter is not law, the regs are. 

    Regulations are law, unlike policy statements or guidance. FDA has made these specific exceptions for a good reason, to encourage unbiased audits.  My point is, the Agency is a creature of law, and inspection is a means to assure compliance, not with the ideas of a single person or group, but with the law as it is written. Non-compliance is a serious matter, a Federal crime. This contrasts completely with the activities of a notified body.  I believe Regulatory personnel have a duty to their companies to understand the law, to keep up with changes in the law, to be aware of  relevant court decisions, and not to simply agree to a request that appears to them to be outside the scope of the law, but to question it.

    I have experienced misinterpretation of regulation and law by inspectors, and can give you an ancient and extreme case in which FDA interpreted "restricted devices" to mean any prescription device (AND had published a notice in the FR to that effect), and insisted upon inspection to the restricted device standard. This was a big company and they refused inspection, FDA disagreed, got a warrant, the Company elected to go to court, and won.(Becton Dickinson and Company v. Food and Drug Administration, NDNY, affd 2nd Cir, 1978). 

    ------------------------------
    Anna Longwell JD RAC
    Principal
    Longwell and Associates
    Palo Alto CA
    United States



  • 30.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 12:59

    When I started in pharma years ago, one of the first lessons I was taught was that "regulations carry the weight of law," with the clear implication that somebody wasn't willing to accept that they actually were law.  That "somebody" was pharma, which did not want to agree that regulations were law, for obvious reasons.  Where pharma has evolved on this issue today, I can't say.

    Yes, mostly BIMO and PMA, which means mostly Class III, which is key here, because it also means less risk averse than the device industry as a whole.  Add my MBA into the mix, and my perspective on this issue is pretty much a foregone conclusion.  In the end, it's all a business decision, and business is all about risk and reward.  It is also all about the interests of the shareholders, which rarely go any further out than the next quarterly or annual financial report.

    I think the overriding point of agreement for everyone here is that whoever is hosting an inspection should be knowledgeable about applicable law.  I think they should also be knowledgeable about the interests of the company.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 31.  RE: FDA Inspection Stories

    Posted 13-Sep-2016 12:43

    quoting Julie..."I think the overriding point of agreement for everyone here is that whoever is hosting an inspection should be knowledgeable about applicable law.  I think they should also be knowledgeable about the interests of the company."

    To me this is imperative. The better you know the regulations, the products being inspected, the quality systems processes and the business, the better job you will do managing an inspection. Being able to read and understand people is also a key. Over the years I have led a lot of inspections, and I have challenged a lot of questions/requests. In general, if you have a good dynamic with the overall inspection, you can find a way to challenge, or discuss an interpretation of a regulation, that does not seem "hostile." A big plus is that by doing so, you always learn a lot. You can also do a lot to explain why your process is perhaps "atypical" but complies with the regulations and have significant back and forth over that. But you can't do either without having a thorough knowledge of the regs, guidances etc.

    A similar approach/style works even when you are pretty sure your documents don't meet the requirements, but it is much trickier because you can't make it look like you or the company truly don't understand the requirements.

    I will say, this skill is extremely hard to teach - those who are good at it tend to have good "people" instincts to start with and are wired to want to understand the regs - but experience does matter a lot even then.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 32.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 21:33

    Hi, Chris.  I love this conversation! And  I'm pleased to see you jump in.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 33.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 11:44

    Chris read this after my response.  Loved it-succinct, terrific contributuion!

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

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  • 34.  RE: FDA Inspection Stories

    Posted 29-Aug-2016 14:52

    One of the biggest problem areas is advertising and promotional stuff.  Once they get in there, they want to become quasi-counsel and they'll send in things they suspect to the Center for a more full review.  We ask our clients to keep the advertising and promotional review process separate and distinct from the quality system because FDA's position if it's in the quality system, they get to look at it.  It's not a correct position, but it makes the argument more difficult.  Don't unnecessarily expose yourself to FDA review of mattes the statute and regulations were never designed to have them look at in a "plant" inspection other than the label and labeling.  If FDA looks closely enough at anything, they will find things they don't like and could result in a promotional warning letter.    Mark

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

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    PLEASE NOTE:  The information contained in this message privileged and confidential, and is intended only for the use of the individual named above and others who have been specifically authorized to receive it. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, or if any problems occur with transmission, please contact sender or call 612.338.7170. Thank you.

     

     






  • 35.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 09:47

    I was in an inspection once and the inspector just stood up and starting walking out of the conference room.  I asked her where she was going and she said she was going to pull files from the file room.  I told her that there may be personal files in there and that we would pull the files and bring them to her.  She insisted on going into the file room and watching us pull the files.  I could maybe see this action if the inspector believed that we were hiding something but she had no reason to feel this way.  We had been promptly delivering everything she requested.

    This inspector was very untrusting from the beginning.  When she called to announce the inspection, she made the comment that she "better not see any altered files dated after this phone call".   In the end there were no 483's issued.

    ------------------------------
    Darlene Garner
    Georgetown TX
    United States



  • 36.  RE: FDA Inspection Stories

    Posted 30-Aug-2016 17:14

    Marc, who is your audience?  Law students?  Engineering students?  Industry personnel?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 37.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 10:26

    Hello Julie -

    I am presenting to a wide ranging group focused on FSMA compliance: https://www.tracegains.com/events

    ------------------------------
    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States



  • 38.  RE: FDA Inspection Stories

    Posted 31-Aug-2016 10:33
    Marc,

    In response to the link provided, it is great you are providing a free webinar.  

    Because the term "fight" sends some interesting connotation, I try hard not to use the term "fight."

    But using the term to be catchy for the (webinar audience), it seems reasonable.

    My previous quote: "professionals are not doing it right unless they fight." 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.