FDA 483 - Hetero Labs Limited - Unit III - September 26, 2025

An FDA inspection conducted at Hetero Labs Limited (Warehouse) in Vishakapatnam, India, from September 19-23 and 25-26, 2025, revealed significant compliance issues. The facility, which stores Active Pharmaceutical Ingredients (APIs), intermediates, and key starting materials intended for the U.S. market, initially denied inspectors access to the warehouse and associated records for approximately two hours. Additionally, the warehouse itself was found to be undisclosed to the U.S. FDA.

The inspection identified critical failures in documentation and quality oversight. There was a lack of proper documentation for incoming material receipts and visual examination for correct labeling. Drums were observed with defaced, torn, or incomplete labels, and handwritten labels lacked essential information. Management claimed unawareness of FDA-regulated materials stored on-site and indicated an absence of quality agreements with FDA-registered manufacturing facilities using the warehouse.

A major concern was the absence of a designated quality unit and adequate current Good Manufacturing Practice (CGMP) controls. The facility operated without written Standard Operating Procedures (SOPs) for crucial activities like material receipt, storage, distribution, environmental monitoring, deviation investigations, or product quarantine and release. Furthermore, there were no complete lot tracking, inventory control systems, or mechanisms for monitoring warehouse temperature and humidity. The company is required to address these deficiencies to ensure compliance with regulatory standards for pharmaceutical materials destined for the U.S. market.