FDA 483 - Hetero Labs Ltd. - Unit IX - November 08, 2022

Hetero Labs Limited Unit-IX, an Active Pharmaceutical Ingredient Manufacturer in Visakhapatnam, India, was inspected by the FDA. The inspection revealed significant deficiencies in out-of-specification investigations, laboratory control mechanisms, data integrity, and facility sanitation procedures. These issues indicate a lack of adequate quality control and oversight in the manufacturing and testing of API products.