Alembic Pharmaceuticals LimitedAugust 30, 2022

FDA 483 - Alembic Pharmaceuticals Limited - August 30, 2022

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Record Details

An FDA inspection of Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer in Vadodara, Gujarat, revealed deficiencies in aseptic processing areas, specifically regarding airflow visualization studies. Additionally, the firm failed to adequately record and justify deviations from written production and process control procedures, with several investigations lacking appropriate preventative actions.

Company: Alembic Pharmaceuticals Limited
Inspection Date: August 30, 2022
Product Type: Drugs
Office: Office of Partnerships
Person: Matthew B. Casale ( Investigator )

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