Regulatory Open Forum

 View Only

  • 1.  EIRs

    Posted 30-Nov-2016 16:39

    I am trying to obtain a copy of an Establishment Inspection Report (EIR) for a recent inspection conducted in March 2016 at one of our contract packaging sites. Note FDA had No Observations.  It is my understanding an EIR is generated by FDA for every inspection – even if there weren't any observations.  Is that correct?

     

    What is the best way to obtain the EIR? I would think our contract packager should be the one following up with FDA as opposed to me.  They have informed us that they have tried contacting FDA but have not gotten any response.  I am wondering if I should try contacting FDA?

     

    Would I contact the FDA District Office that conducted the inspection or the Center in D.C.? I believe the inspector has to submit his report to the Center within 30 days, but the EIR is issued from the Center to the packager, correct?

     

    It's been 8 months since the inspection so I would have expected our packager would have received the EIR by now.  What is the standard timeframe for FDA to issue the EIR?

     

    Any guidance on possible options for obtaining the EIR is greatly appreciated.

     

    Thank you.

    Tom

    Chicago

     



  • 2.  RE: EIRs

    Posted 01-Dec-2016 06:50
    Tom,

    The EIR is generated after every inspection.  Other than through an FOI request, it is only available to the inspected entity.  The firm is generally notified at the time of inspection close-out how to obtain an EIR.  Otherwise, I have had success using an email to the Inspector requesting the EIR.  If that doesn't work, I would suggest contacting the district office responsible for the inspection.  I would not contact the Center unless all else fails, and then only through DSMICA.  Keep in mind that the EIR is not available until the inspection is completed and classified by the District Compliance Officer as NAI or VAI, possibly with input from the Office of Compliance.  Even though you note that the inspection was completed with no observations, that may be only part of the story.  Since this is a contract manufacturer, the inspection may have been prompted by issues at one of their other customers and that matter may still be open.  If it is, then the EIR would not necessarily be available.

    James



    Original Message


  • 3.  RE: EIRs

    Posted 02-Dec-2016 08:22

    I've had at least three instances where there was no 483 and the EIR was not sent to the firm (a domestic establishment) for more than a year after the inspection.  In all three cases, the firm was a contractor. In all three cases, the Districts simply said they were busy and would get to it as soon as possible.  I don't think this is usual and all three cases occurred more than two three years ago.

     

    As an aside but on the same topic of EIRs being issued, the oddest thing I've experienced is a District that issued the EIR to the inspected firm as an FOIA redacted version. 

     

    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

     




    Original Message


  • 4.  RE: EIRs

    Posted 01-Dec-2016 08:45

    Generally, if the FDA did not send the vendor a copy of the EIR they are willing to share, the only way to obtain the EIR is through FOIA. I recently requested an EIR through FDA's electronic FOI request form, and surprisingly (given the usually slow nature of FOI fulfillment) I received it from that District within a month.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States

    Original Message


  • 5.  RE: EIRs

    Posted 01-Dec-2016 11:43

    Sometimes it is not a priority to issue an EIR, particularly if there are no observations. We once waited almost a year, and the EIR was finally issued when another FDA inspector asked us to see it on an unrelated inspection 11 months later.

    ------------------------------
    Charles P. Van Beveren, PhD
    San Diego CA
    United States

    Original Message


  • 6.  RE: EIRs

    Posted 05-Dec-2016 10:03

    Thank you all for your feedback. Very useful information.  We were just provided the EIR from our packager.  It was dated July 2016 so I think they had it all along.

    Tom




    Original Message