FDA 483 - Hetero Labs Limited (Warehouse) - September 25, 2025

Hetero Labs Limited (Warehouse) in Vishakapatnam, India, was inspected and cited for severe deficiencies in its operations. The inspection revealed a denial of access to the warehouse, an undisclosed facility status with the FDA, and a complete lack of quality unit oversight and essential cGMP controls. Significant issues included undocumented material receipt, improper labeling, absence of SOPs, inadequate inventory management, and widespread contamination risks from damaged containers and pest infestations.