FDA 483 - Alembic Pharmaceuticals Limited - February 06, 2021

Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer located in Vadodara, Gujarat, India, was inspected by the FDA from January 28 to February 6, 2021. The inspection revealed several critical deficiencies in their aseptic processing and environmental monitoring systems.

Key violations included inadequate monitoring of environmental conditions in aseptic processing areas. The firm failed to justify scientifically why certain areas were not sampled for contamination risk, particularly in Grade B areas where incidents of potential contamination were observed. Additionally, integrity testing for equipment used in Grade A and B areas was not performed, and the rationale for this omission was not provided.

The inspection also highlighted deficiencies in the firm's personnel monitoring program, which did not include testing of aseptic filling operators' shoulders, despite potential contact with critical areas. Furthermore, improper gowning practices were observed among employees, potentially compromising sterile conditions.

Alembic Pharmaceuticals was found lacking in validating and controlling processes to prevent microbiological contamination. Specifically, the performance qualification for a key production line did not provide scientific evidence to ensure the sterility of the product contact surfaces.

The FDA has required Alembic Pharmaceuticals to address these issues by providing scientific justifications, conducting necessary integrity tests, and improving their environmental and personnel monitoring protocols to comply with regulatory standards. These actions are crucial to ensure the safety and efficacy of their sterile pharmaceutical products.