FDA 483 - Hetero Drugs Ltd. - Unit 1 - March 02, 2018

An FDA inspection conducted from February 26 to March 2, 2018, at Hetero Drugs Ltd. - Unit 1, an Active Pharmaceutical Ingredients manufacturer in India, revealed five significant observations concerning compliance with Good Manufacturing Practices. The company failed to thoroughly investigate unexplained discrepancies, specifically not extending an out-of-specification (OOS) result for water content to the manufacturing process. The Quality Control Unit also did not adequately qualify or routinely audit suppliers of critical GxP computerized systems, including Empower 3 Software, Laboratory Information Management System (LIMS), and Warehouse Management Portal System (WMPS), contrary to their own internal procedures. A major concern was the lack of properly trained and experienced employees, with multiple personnel unable to explain their assigned functions or critical process steps in various departments. Production equipment was observed to be dirty, posing a risk of product contamination. Furthermore, the Microbiology laboratory exhibited deficient controls, storing cleaned glassware uncovered near unclean items and lacking proper labeling, creating a potential for mix-ups. Hetero Drugs Ltd. is expected to promptly address these observations to ensure adherence to regulatory standards.