FDA 483 - Hetero Drugs Ltd. - Unit 1 - May 16, 2025

Hetero Drugs Ltd. - Unit 1, an API manufacturer in Gummadidala, Telangana, India, was cited with two observations during an FDA inspection. The firm failed to conduct adequate risk assessments and testing for the formation of a known carcinogen in drug products and lacked proper cleaning validation procedures to prevent hazardous drug residue cross-contamination on shared equipment. These issues indicate significant concerns regarding product quality and safety.