FDA 483 - Hetero Labs Limited (Warehouse) - September 26, 2025

Hetero Labs Limited's warehouse in Vishakhapatnam, Andhra Pradesh, India, was inspected by the FDA from September 19 to 26, 2025. The inspection revealed significant compliance issues, primarily concerning access and documentation related to the storage of active pharmaceutical ingredients (APIs), intermediates, and key starting materials (KSMs) intended for the U.S. market.

Key violations included the denial of immediate access to the warehouse for approximately two hours, during which time security personnel refused entry to FDA inspectors and prevented inspection of a truck loaded with drums. Additionally, the warehouse was not disclosed to the FDA, and there was a lack of documentation for the receipt and labeling of materials. Observations noted included the presence of drums with defaced or handwritten labels lacking essential information such as manufacturer name, customer name, storage conditions, and grade designation.

The regulatory framework requires that facilities handling materials for the U.S. market maintain transparency and proper documentation to ensure compliance with FDA standards. Hetero Labs Limited must address these issues by ensuring immediate access to facilities for inspections, properly documenting all materials, and maintaining accurate labeling practices. Failure to comply could lead to further regulatory actions. The company is advised to discuss objections or corrective actions with FDA representatives and submit relevant information to the FDA.