Regulatory Open Forum

 View Only

  • 1.  483 Responses - Following up with FDA

    This message was posted by a user wishing to remain anonymous
    Posted 10-Oct-2018 16:51
    This message was posted by a user wishing to remain anonymous

    A few weeks ago I submitted the second and final response to the local FDA DO regarding two 483 observations issued back in the summer. Is it appropriate to follow up with the DO to see if they have reviewed the information or require any additional information? If so, what would be an appropriate time to do this?

    Thanks


  • 2.  RE: 483 Responses - Following up with FDA

    Posted 11-Oct-2018 04:58
    Hello,

    They are usually fairly responsive, just depends on their workload; I find most usually respond they have received and/or accepted the Form 483 response.  Though there are times that I had not received any response, so I sometimes followed up around day 60, but more often than not I did not follow-up at all ... 'no news is good news' approach.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: 483 Responses - Following up with FDA

    Posted 11-Oct-2018 07:01
    FDA will only recognize and acknowledge FDA-483 response letters received by the agency within the time limit of 15- workdays following the issuance of the FDA-483 (unless specifically FDA requests additional information).  FDA will base any regulatory action decisions on information received in responses within the 15 days.  Additional follow-up responses after the 15-day period are frequently made by companies, but these will not be formally reviewed or acknowledged by FDA and simply will be placed in the company files.  These additional responses may eventually be reviewed by Investigators in preparation for the next inspection.  However, there is no value in asking the FDA District Office for feedback or if they have reviewed responses sent after the 15-day limit.

    ------------------------------
    Peter Smith
    Principal
    Smith GMP Consulting
    Narragansett, Rhode Island
    USA
    ------------------------------

    Original Message


  • 4.  RE: 483 Responses - Following up with FDA

    Posted 12-Oct-2018 08:07

    ​Similar to other's experience, I typically follow up shortly after submission to ensure FDA received the responses on time, then wait for feedback.  FDA has historically been very diligent in reviewing.   

    I would be very surprised if comments from FDA came back more than 2 months after the response was submitted.   However, if the proposed mitigation strategy is business critical, it would be appropriate to follow up 6-10 weeks after submission with a polite inquiry.

    Best regards,

    Cathy



    ------------------------------
    Catherine Anderson PhD, RAC
    Senior Manager - Regulatory CMC
    Hillsborough NC
    United States
    ------------------------------

    Original Message


Related Content