483
Alembic Pharmaceuticals LimitedAlembic Pharmaceuticals Limited – FDA 483, Aug 30, 2022
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.
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ID · ec07c909-af00-4f98-8c1e-5b31d2cd34dc
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