FDA 483 - Alembic Pharmaceuticals Limited - January 28, 2021

An FDA inspection conducted from January 28 to February 6, 2021, at Alembic Pharmaceuticals Limited"s sterile pharmaceutical manufacturing facility in Vadodara, India, resulted in significant observations documented in a Form 483. The inspection highlighted deficiencies primarily in two critical areas: environmental monitoring of aseptic processing areas and validation of aseptic and sterilization processes. Regarding environmental monitoring, the firm lacked scientific justification for its sampling locations, failing to demonstrate that these represented the highest risk for product contamination, with specific contact surfaces and personnel areas not adequately sampled. Additionally, inspectors observed instances of improper gowning in Grade A aseptic manufacturing areas. The inspection also revealed inadequate validation and control processes for critical aseptic and sterilization steps. Alembic failed to provide scientific evidence validating sterilization effectiveness for critical equipment, and engineers performing interventions in Grade A aseptic areas were not sufficiently qualified. Concerns were also raised about the inadequate placement of non-viable particle probes and biological/chemical indicators during equipment qualification. These observations indicate a need for comprehensive corrective actions to ensure the sterility and quality of drug products manufactured under the regulatory framework for sterile pharmaceuticals.