FDA 483 - Panacea Biotec Pharma Limited - February 20, 2020

Panacea Biotec Limited, a manufacturer in Baddi, India, was inspected and cited for significant deficiencies across its production and laboratory control systems. Key issues include inadequate environmental monitoring in aseptic processing, lack of proper microbiological contamination prevention procedures, and insufficient production controls for product quality. Furthermore, the firm's laboratory controls exhibited multiple failures in test procedures, record-keeping, and validation of sterilization and testing methods.