FDA 483 - Panacea Biotec Pharma Limited - August 09, 2019

Panacea Biotec Limited, a drug manufacturer in Baddi, India, was inspected by the FDA from August 5-9, 2019. The inspection revealed significant issues with change control procedures, specifically regarding the scientific justification for changes to production processing parameters. Additionally, the firm failed to implement corrective and preventive actions identified during drug complaint investigations.