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  • 1.  QSR -FDA medical devices audit

    Posted 07-Nov-2017 19:05

    Hi,

     

    We are a medical devices company, manufacturing Class II devices, in process of undergoing an FDA audit shortly. Would be really helpful if  you could share your experiences from the FDA audit , relevant guidances /checklist.  

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     



  • 2.  RE: QSR -FDA medical devices audit

    Posted 08-Nov-2017 08:42
    FDA is not performing an audit, they are performing an investigation. This distinction is very important. They are gathering evidence that you do or do not conform to regulations and this is a legal activity. If they find evidence that shows non-compliance  they can take legal action against the company and in the case of serious violations such as lying and destruction of records, they can take criminal action against (usually) top management or individual employees. 

    That should shape have your approach to the inspection and you should be aware of legal rights. One tactic that the FDA Investigator ( the title of the person that will be at your facility) may use is to ask that a person sign an affidavit.  NEVER, never, never sign a document at the investigators request, it is your legal right to refuse to sign such a document. 

    If if you are asking the question you have posted, I believe you need to seek more advice than this posting here. You need qualified consultants to help you and you may need a regulatory attorney in case of significant findings that result. 

    You also need need qualified help on standby in case of FDA-483 resulting from the investigation as you only have 15 days to send a written response to the FDA. If your response is not there in 15 days additional action can be taken such as issuance of a Warning Letter. 

    You need to to start your preparation for FDA even before notification by FDA that they will be coming. Do you have an SOP on how to manage an inspection? Lots to do so little time. Get help today!

    ------------------------------
    Edwin Bills RAC, MA
    Principal Consultant
    Edwin Bills Consultant
    Overland Park KS
    United States
    ------------------------------

    Original Message


  • 3.  RE: QSR -FDA medical devices audit

    Posted 08-Nov-2017 09:29
    Hi, Rashmi,

    In addition to Edwin's comments, since you are outside the US you will hopefully have more time to prepare.  Here in the USA we usually get about 1 week's notice.  In the mean time you can read up on what to expect in the FDA's QSIT Guide.  Google FDA QSIT inspection and QSIT inspection checklist and read up. 

    Having a thrid party conduct an audit based on the QSIT is a good way to identify your weak spots and your team by having a run through.  Be aware that the investigator will often start with looking at your CAPA's to see what problems you have already identified as well as see how you handle quality system corrections.

    There are some additional policies for the FDA conducting foreign inspections.  They can be found here:
    Chapter 3 ESTABLISHMENT INSPECTIONS
    Fda remove preview
    Chapter 3 ESTABLISHMENT INSPECTIONS
    Subchapter 310 MANAGEMENT RELATIONS 311 NOTICE OF INSPECTION 312 REPORTABLE OBSERVATIONS 312.1 Non-reportable Observations 312.2 FDA-483 Annotations 312.3 Comstat/Contract Requirement Deficiencies 312.4 Distribution of the Form FDA 483 313 RECEIPT FOR SAMPLES 314 REFUSALS 315 DISCUSSION WITH MANAGEMENT 315.1 Procedure for Discussion of Observations 315.2 Protection of Privileged Information 315.3 Freedom of Information (FOI) Act 316 POST INSPECTION NOTIFIFCATON 317 ESTABLISHMENT INSPECTION REPORT 301 AUTHORITY Section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines interstate commerce as "commerce between any state and any place outside thereof."
    View this on Fda >

    Regards,

    ------------------------------
    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
    ------------------------------

    Original Message


  • 4.  RE: QSR -FDA medical devices audit

    Posted 08-Nov-2017 19:32

    Hi,

     

    Thanks for your feedback, would also be helpful to know if anybody's got a  comparison chart readily available for the FDA QSR compliance vs the ISO 13485 :2003/2016 . We are ISO 13485 :2003 compliant and in the process of compliance with 2016 version , so if the ISO  checklist takes care of most of the requirements , we need to work on only the gap.

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 5.  RE: QSR -FDA medical devices audit

    Posted 09-Nov-2017 08:56

    ​You may be able to find a comparison chart from this group or online but they can be misleading. The ISO 13485 standard and the FDA QSR are very similar, but there are differences and in an FDA inspection the QSR is the only thing that matters. What seems to be small changes like how words are used can mean the difference between getting a 483 observation or not. Using somebody else's comparison chart WILL provide a false sense of security. This is an occasion where there is no substitute for reading every line of the QSR and understanding exactly how your QMS complies.

    Also, don't forget that there are other regulations besides the QSR that FDA will inspect you against. If you are a manufacturer distributing product in the US, FDA will inspect against 21 CFR 803 Medical Device Reporting and 806 Reports of Corrections and Removals. EU/ISO terminology in your procedure will guarantee 483's. Lack of compliance to these regulations (especially 803) shows up in Warning Letters often. FDA will expect to see the US requirements in your procedures to include definitions and timeline requirements. If you use electronic records, Part 11 will apply, and so on.

    The difference between an ISO audit and an FDA inspection has to be experienced to be appreciated. Having an ISO 13485 compliant QMS is a good start but the devil really is in the details.

    Good luck!



    ------------------------------
    Ian Christianson
    Marlborough MA
    United States
    ------------------------------

    Original Message


  • 6.  RE: QSR -FDA medical devices audit

    Posted 09-Nov-2017 09:36
    While the ISO 13485 standards and 21CFR820 are similar, the approach to audits and inspections are different. I agree with pretty much everything John and Ed said - it would be well worth your while to have a "mock" inspection by a consultant with FDA experience. I tend to always do this before an inexperienced company has an FDA inspection.

    You should read the FDA documents, particularly the Compliance Policy guide and everything on the Quality Systems Inspectional Technique (QSIT). As a super-quick overview, FDA will generally approach a "routine" inspection using QSIT.

    Management controls - expect them to look closely at Management Review, internal audit etc
    CAPA/Complaints/MDR - FDA will spend a lot of time on these, both to make sure you are following the regs (filing MDRs appropriately, trending complaints etc) and to assess what else they may want to look at. They usually sample X% of complaint files and CAPA files.

    Design controls - make sure you can show how all the elements of DHR are complete and accurate Expect them to read test reports etc and look for anomalies

    Process controls - inspection, calibration, process validations etc. This is a focus area, particularly process validation

    Again, I really would encourage you to have a "mock audit" to practice and learn. Any number of us on this forum can give you some contact names to do this if you want them.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Engineering
    MN
    ------------------------------

    Original Message


  • 7.  RE: QSR -FDA medical devices audit

    Posted 09-Nov-2017 17:25
    ​Hi Ginger ,

    Thanks for your feedback , can you give me some good contacts for mock inspections. Since we are based in Australia , it would be preferable to have someone from here.

    Regards,

    Rashmi


    ------------------------------
    RashmiEllex MedicalAdelaideAustralia
    ------------------------------

    Original Message


  • 8.  RE: QSR -FDA medical devices audit

    Posted 10-Nov-2017 08:00
    ​All of the above are very worthwhile recommendations. If I am reading your account correctly, then you did not take the FDA's regulations into account to a high degree. Instead you were basing your QMS on ISO 13485:2003, which in itself is not bad and a good starting point to ensure FDA-compliance. In short, from my perspective :

     

    before the inspection : follow all of the recommendations posted here above under the guidance of an experienced consultant(s).

     

    during the inspection : make sure that everyone within your organization understands which role he/she has to play (or not play) during the inspection. Select the best person(s) to interact with the FDA investigator. Ensure you can readily and correctly present any documentation the investigator asks for.

     

    after the inspection : know how to respond to any "observations" on the FDA Form 483. As pointed out above, there is 15 day limit for sending in your written response. But also ensure that your response is as complete as can be, including (as applicable) copies of updated SOPs, training records of employees to the updated SOPs, any CAPAs already completed, and a realistic timeframe for CAPAs not yet completed.



    ------------------------------
    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.
    Lausanne
    Switzerland
    ------------------------------

    Original Message


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