FDA 483 - Panacea Biotec Pharma Limited - October 12, 2023

Panacea Biotec Pharma Limited, a sterile and non-sterile drug manufacturer in Solan, India, received a Form 483 with nine observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, personnel training for visual inspection, and laboratory controls. These issues indicate a lack of robust procedures and oversight to ensure the sterility and quality of drug products.