FDA 483 - Alembic Pharmaceuticals Limited - October 28, 2021

A recent FDA inspection conducted at Alembic Pharmaceuticals Limited D sterile drug manufacturing facility in Vadodara, Gujarat, India, from October 28 to November 10, 2021, identified significant deficiencies in control procedures and process validation. The Form FDA 483 report detailed multiple issues regarding the company"s adherence to Good Manufacturing Practices (GMP) for sterile products.

Key violations included a failure to establish adequate control procedures for monitoring manufacturing output and validating process performance, which could lead to variability in drug product characteristics. Specifically, the firm did not fully qualify or validate critical equipment and processes used for sterile product manufacturing. Issues cited were the lack of cleaning validation for non-dedicated production lines and "worst-case" products, unvalidated cleaning hold times, and absence of filter integrity testing. Furthermore, the company failed to establish critical process parameters, did not consistently use biological indicators to ensure sterilization efficacy, and lacked scientific justification for environmental monitoring locations.

Additionally, the inspection found that procedures designed to prevent microbiological contamination of sterile drug products were inadequate due to insufficient validation of the sterilization process, including deficiencies in media fill studies for multiple manufacturing lines. Alembic Pharmaceuticals is required to address these observations to ensure the safety and quality of its sterile drug products and comply with regulatory standards.