FDA 483 - Hetero Labs Ltd. - Unit IX - September 26, 2025

Hetero Labs Limited, Unit-IX, an API manufacturer in Narasapuram Village, India, was cited for significant quality control and data integrity issues during an FDA inspection. The firm was found to be using an unregistered testing laboratory and an undocumented offsite warehouse, leading to a lack of traceability for APIs and intermediates. Additionally, the inspection revealed destroyed GMP documents, falsified training agreements, and uninvestigated Out of Specification results, indicating severe deficiencies in their quality unit and record-keeping practices.