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.
Original Message:
Sent: 31-Aug-2016 12:58
From: Julie Omohundro
Subject: FDA Inspection Stories
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.
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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
Original Message:
Sent: 31-Aug-2016 12:09
From: Anna Longwell
Subject: FDA Inspection Stories
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).
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Anna Longwell JD RAC
Principal
Longwell and Associates
Palo Alto CA
United States
Original Message:
Sent: 29-Aug-2016 23:52
From: Julie Omohundro
Subject: FDA Inspection Stories
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.
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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
Original Message:
Sent: 29-Aug-2016 15:53
From: Anna Longwell
Subject: FDA Inspection Stories
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.
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Anna Longwell MS, JD RAC
Principal
Longwell and Associates
Palo Alto CA
United States
Original Message:
Sent: 29-Aug-2016 14:00
From: Christopher Smith
Subject: FDA Inspection Stories
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