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From: Smith, Michael (CBER)
Sent: Monday, August 16, 2021 10:38 AM
To: Harkins Tull, Elisa <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin,
Carmel M <[email protected]>; Rohlfing, Paul <[email protected]>
Subject: STN 1 25742.0: IR RE diluent suppliers
Elisa,
The review team has the below information request for you regarding your diluent suppliers:
Due to the Warning Letter (reference WL 320 -20-31 issued 03/25/2020) and
Official Action Indicated status of Pfizer Healt hcare India Pvt. Ltd. (FEI#
3008316085), the Agency will not approve the diluent supplied from that manufacturer as part of your BLA. Please acknowledge this notification and
remove all references to this supplier from the BLA, including in the recently
added Diluent Manufacturers table.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
FDA-CBER-2021-5683-1150260
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FDA-CBER-2021-5683-1150261