No, I don't think so. That activity is not required to be identified in the Manufacturer section of the dossier, so I wouldn't think you would need to register. If you want to be certain you could email your question to
edrls@fda.hhs.gov. I've found them to be pretty helpful.
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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 22-Aug-2022 16:49
From: Anonymous Member
Subject: FEI required for sterilization testing?
This message was posted by a user wishing to remain anonymous
If the manufacturer detects a contaminant in their product, we will identify what the contaminant is to aid in troubleshooting and resolution of the source of contamination.
Original Message:
Sent: 22-Aug-2022 10:34
From: Rachel Thornton
Subject: FEI required for sterilization testing?
What do you mean by sterilization testing?
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Rachel Thornton
Associate Director
Smyrna GA
United States
Original Message:
Sent: 15-Aug-2022 09:41
From: Anonymous Member
Subject: FEI required for sterilization testing?
This message was posted by a user wishing to remain anonymous
My company will be performing sterilization testing for a biologics manufacturer. Based upon the Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers, it is unclear to me if we are required to obtain an FEI? In addition, what are the obligations if we do request an FEI, are we required to follow GMP and/or does it open us up to FDA inspections? Thank you for your thoughts.