483
Biovectra, Inc.Biovectra, Inc. – FDA 483, Aug 26, 2022
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.
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ID · e0f39d73-a345-4e14-9e5c-c2f807135e5d
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