FDA 483 - Alembic Pharmaceuticals Limited - December 16, 2022

Alembic Pharmaceuticals Limited, a non-sterile drug manufacturer in Vadodara, India, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate equipment cleaning and maintenance, lack of procedures to prevent objectionable microorganisms, and failures in production and process controls. The firm also demonstrated deficiencies in environmental monitoring and a systemic failure to follow deviation management procedures for critical equipment breakdowns.