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

Hetero Labs Limited, Unit-IX, an API manufacturer in Narasapuram Village, Andhra Pradesh, India, underwent an FDA inspection from September 19-26, 2025. The inspection, based on Good Manufacturing Practices (GMP) principles, identified two critical observations concerning the firm"s quality control and material management. The first major issue involved the company"s undisclosed use of an unregistered testing laboratory for analyzing Active Pharmaceutical Ingredients (APIs) and intermediates intended for the U.S. market. This external facility was not listed in the firm"s Drug Master Files. FDA investigators found extensive evidence at the unregistered site, including API samples, intermediates, original analytical records, equipment logs, and internal communications directly linking it to Hetero Labs" operations, despite employee claims of unawareness regarding sample transfers. No formal quality agreement was in place with this facility, and company IT and HR records confirmed corporate ties. The second observation highlighted the undocumented release and storage of finished APIs and intermediates destined for the U.S. market at an unauthorized offsite warehouse. This facility lacked essential procedures and records for receiving, inspecting, and continuously monitoring storage conditions such as temperature and humidity. There were also no documented procedures for investigating storage excursions or maintaining proper segregation of materials. Hetero Labs Limited is now required to implement comprehensive corrective actions to address these systemic deficiencies, ensuring all testing and storage facilities are properly registered, fully documented, and operating in strict adherence to FDA regulatory requirements for drug product quality and safety.