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FDA inspection pre-announcement, specific situation

Discussion in 'US Medical Device Regulations' started by Somashekar, Mar 12, 2016.

  1. Somashekar

    Somashekar Moderator Staff Member

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    Hi experts... need advice
    We all in this case (A, ^A, B, C) are a part of the same corporation.
    Due to changes in business in late 2015 our principles A in usa have not continued their FDA establishment registration for year 2016. They propose to change the name as ^A and register again in FDA database with a new address in 2016. We in India are the contract manufacturer B for A (class 2 devices) and are FDA registered with A's devices listed under us as contract manufacturer, manufacturer. B is also an ISO 13485:2003 certified company, and have an NDA established with A.
    ^A is not certain if they want to continue the contract manufacture association with B.
    Going into 2016, our FDA registration is renewed with no changes by our usa agent C. Presently, we are not doing any contract manufacture activity for A.
    Now FDA have sent B in India an inspection pre announcement mail for May 2016, requesting the firm profile in a prescribed form, and the quality manual. B have shared the same. B also informed FDA that some changes have recently happened with principles A and that the same are yet to be incorporated into the quality manual as well as the changes update in the FDA establishment registration and device listing. B also mentioned in the firm profile sent to FDA, that the design controls are the process that was with A.
    1. From here on what can be the likely course that FDA will take ?
    2. What can be the course that B must take ?
    3. What can be the course that B has to ask C (usa agent of B) to take ?
    4. When the FDA inspection happens perhaps in May 2016, B will have minimum headcount and no work on hand. What can be the likely inspection outcome ?
    If I have missed out any detail, please do ask.

    Thanks ... :)
     
    Last edited: Mar 12, 2016
  2. MarkMeer

    MarkMeer Well-Known Member

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    Are they inspecting B because of the contract-manufacturer relationship with A? Or is it just a standard random international establishment inspection?

    If the latter, I don't know that they care too much about the future relationship changes...as long as they know your CURRENT activities (including whatever present relationship is with A), and can conduct their QSIT inspection accordingly.
    If the former, the focus may just be on the establishment, implementation & control of A's design controls...I don't know.

    I don't think that there's anything for C (the US agent) to do with respect to foreign inspections. They'll likely just be kept CC'd on any email correspondences with the FDA, and forward you any requests the FDA might send them for additional/missing information.

    It shouldn't matter, as long as someone is there who can access records and knowledgeable enough to represent the company and answer questions. In my experience, they are all about the documentation (records, procedures...)...less about interviewing specific personnel, or inspecting active production activities.
     
    Somashekar likes this.
  3. Somashekar

    Somashekar Moderator Staff Member

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    Thanks Mark... You give me a lot of confidence.
     

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