Biovectra, Inc.August 26, 2022

FDA 483 - Biovectra, Inc. - August 26, 2022

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Record Details

An FDA inspection of BioVectra Inc., an Active Pharmaceutical Ingredient manufacturer in Charlottetown, Canada, revealed two significant observations. The firm failed to consistently follow procedures for environmental monitoring, specifically regarding non-viable particulate excursions in a cleanroom. Additionally, the company did not adhere to its master schedule for completing annual product reviews for Active Pharmaceutical Ingredients.

Company: Biovectra, Inc.
Inspection Date: August 26, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Jonathan G. Matrisciano (Program Division Director/District Director)

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ID · e0f39d73-a345-4e14-9e5c-c2f807135e5d