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  • 1.  FDA Response to Firm's 483 Response

    Posted 21-Jun-2016 20:04

    Dear All,

    When will the FDA respond to a firm's 483 response and CAPAs and determine the response and corrective action is appropriate/acceptable? Is there a time period?

    Thank you.

    David 

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    David Lucking
    Coral Gables FL
    United States
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  • 2.  RE: FDA Response to Firm's 483 Response

    Posted 22-Jun-2016 05:52

    David

    FDA does not normally respond. If your response to the 483 was sent within the 15 working day period, it will be assessed by FDA

    FDA may respond, but don't have to. An unwanted response could be a Warning Letter

    Regards

    Siegfried

    ------------------------------
    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
    siegfried.schmitt@parexel.com

    Original Message


  • 3.  RE: FDA Response to Firm's 483 Response

    Posted 22-Jun-2016 08:50

    Hi,

    It all depends on how soon Submission to 483 Response get reviewed by FDA and also depend on which district office your firm is located. As soon as submission reviewed, FDA will conduct site inspection to close CAPA and give GMP clearance. As per my own experience, I had sent Response to 483 back in March 2016. And this week of June 22, 2016, FDA is conducting onsite inspection to close CAPA. So after all, it is all about time submission review and FDA's scheduling for site inspection. Hope this help. 

    Thanks,

    Prakash 

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    Prakash Patel
    Sr. Regulatory Submission Management
    Roche (TCS)
    Midland MI
    United States

    Original Message


  • 4.  RE: FDA Response to Firm's 483 Response

    Posted 22-Jun-2016 10:17

    David:

    Firms have 15 working days in which to respond to FDA's inspectional observations.  That is based on former Commissioner Hamburg's pronouncement that was published in the Federal Register shortly after she took office.  However FDA is under no similar obligation to offer a detailed acknowledgement of a firm's response within a specific timeline.  For example, one of the foreign client's I am working with has yet to receive a reply from FDA to its response to several Discussion Items raised by the FDA investigator (i.e. issues that were not significant enough to warrant being cited on a 483).  In other words, no 483 was issued, but the firm elected to submit a response for the Discussion Items.

    Some District Offices (and in the case of foreign inspections, the corresponding Office in the Center with jurisdiction over the products being inspected) are better than others at providing a timely.  That reply may consist of little more than an acknowledgement that the firm's response has been received and is under review.

    Having been an  FDA Compliance Officer and Branch Director, I always recommend trying to establish a line of communication with the compliance officer that is responsible for reviewing the firm's Establishment Inspection Report (EIR). 

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    Mark Lookabaugh
    Principal Consultant
    PAREXEL International, LLC
    Stafford Springs CT
    United States
    mark.lookabaugh@parexel.com

    Original Message


  • 5.  RE: FDA Response to Firm's 483 Response

    Posted 22-Jun-2016 11:16
    David,

    Responses from others seem to warrant few words from me to add to.

    First, firms' responses to the 483s are viewed as "unsolicited" responses as it is not required by law and thus, FDA is not obligated to reply.  The FDA has elected not to reply to the 483 responses for several reasons.  When they do, they don't go beyond simple acknowledgement of the receipt of the response. There are few exceptions. 

    Interestingly, FDA FMD-120 states "Districts will issue a timely reply to all contact and correspondence from firms regarding FDA 483s..." 

    In fact, FDA investigators/inspectors are trained not to reply to the 483 responses regarding the adequacy of the firm's response to 483s. IOM 5.1.2.6

    Industry's common mistakes that I have observed:  industry professionals seem to treat FDA investigators/inspectors as "authoritative" consultants, which is mistaken. 

    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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    Original Message


  • 6.  RE: FDA Response to Firm's 483 Response

    Posted 23-Jun-2016 06:23

    If your response is adequate, you will receive a copy of the Establishment Inspection Report (EIR).  The EIR is issued once the inspection is closed and no further action (on the part of FDA) is warranted.  If your response is not adequate and the 483 observations are significant, you will probably hear from FDA via a Warning Letter.

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    Peter Ohanian RAC
    Principal Consultant
    Halloran Consulting Group
    Windham NH
    United States

    Original Message


  • 7.  RE: FDA Response to Firm's 483 Response

    Posted 23-Jun-2016 22:06

    It seems to me that what you may really be asking is how long are you going to be left hanging, not knowing the final result?  Perhaps this link will be of some assistance:

    http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056246.htm

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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