Biovectra, Inc.February 17, 2017

FDA 483 - Biovectra, Inc. - February 17, 2017

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An FDA inspection of BioVectra Inc. in Charlottetown, PE, Canada, identified a significant issue with the firm's stability program. The company consistently failed to complete stability testing in a timely manner for several batches of Bulk API. This indicates a failure to follow their own standard operating procedures for administering a stability program.

Company: Biovectra, Inc.
Inspection Date: February 17, 2017
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Tonya R. Johnson (Chemist)
Stacie A. Woods (Account Director)

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ID · 3bf401c7-eb39-461b-8c0f-cdd5e373fe9b