FDA 483 - Apothecon Pharmaceuticals Private Limited - January 27, 2023

Apothecon Pharmaceuticals Private Limited in Vadodara, India, was cited for significant deficiencies across its laboratory, quality, material, and facilities systems during an FDA inspection. Observations included failures in OOS investigations and data reporting, inadequate test method validation, and insufficient laboratory controls. The firm also failed to properly manage returned drug products and ensure continuous temperature monitoring for critical storage equipment.