FDA 483 - Alembic Pharmaceuticals Limited - November 10, 2021

Alembic Pharmaceuticals Limited received a Form 483 citing significant deficiencies in its manufacturing processes for sterile products. Observations included failures in equipment and process validation, inadequate media fill studies, and a lack of thorough investigations into out-of-specification results and non-conformances. The firm also had issues with environmental monitoring, cleaning procedures, quality control unit responsibilities, and computer system controls.