Hetero Warehouse Flagged for Serious Lapses in Material Controls by USFDA

FDA conducted an inspection at the Hetero Labs Ltd, Warehouse at Nakkapally Village, Vishakapatnam, Andra Pradesh, India, 531081 (FEI 3040501127) and observed serious lapses in material storage, traceability and control, documentation, cross contamination, contamination controls, pest control at the Warehouse. The site was inspected by investigators Guerlain Ulysse, Constance Richard-Math, between 19 – 26 September 2025.

This inspection was conducted at same time the FDA inspected Hetero Labs Limited’s Unit IX API manufacturing facility (3009093782) at Plot No 2, Hetero Infrastructure SEZ, Narasapuram Village, Andhra Pradesh, 531081, India.

 Observation 1: Refusal of Inspection

When USFDA investigators arrived at the warehouse which was storing multiple drums and bags of API, intermediates and key starting materials (KSMs), they were denied access to the warehouse for almost two (2) hours. The gates of the warehouse which were wide were lowered and shut and personnel at the warehouse ran out of plain sight. A truck full of drums did not allow inspection and left the facility without any explanation; another truck was turned away by the security.

Observation 2: Storage without documentation and control

The undisclosed warehouse was holding APIs, Intermediates and Key starting materials (KSMs) for USFDA registered manufacturing facilities. There was no documentation of incoming receipt or visual examination. Labels on the drums were defaced or partially torn or cut, drums had hand written labels with no manufacturer’s name, customer’s name, storage conditions or grade designation. The Assistant Manager Warehouse and Assistant Vice President (AVP) stated many drums contained recovered material and the warehouse is only used to store materials for Hetero Unit III facility for Indian domestic market. They officers claimed they unaware of Hetero Unit IX drums or other FDA registered manufacturing facilities drums at the site and how, why, and when these drums were transported to the warehouse.

Observation 3: No Quality Unit oversight.

There was no functioning quality control unit and no cGMP controls for receipt, storage and distribution of APIs, intermediates and raw materials at the warehouse. Facility operated without any standard operating procedures for receipt, storage, distribution, environmental monitoring, handling of cold storage products, investigation of deviations, handling of complaints and recalls, material quarantine, training of personnel. There was no certificate of analysis of materials. A Senior Manager of Hetero Corporate Quality Assurance (CQA) who visited the warehouse to investigate why Hetero Unit IX drums are being stored in the warehouse stated he was unaware of practices and operations concerning the warehouse.

Observation 4: Lack of inventory control and monitoring

No procedures describing warehousing of APIs, Intermediates and raw materials were established at the warehouse and there was no lot tracking and inventory control systems in place. There was no mechanism for monitoring warehouse temperature and humidity or the 2-8°C cooler and the warehouse was open to environment.

Observation 5: Risk of Mix up

 There are no procedures for segregation of rejected, released, or quarantined material, no first-in, first-out (FIFO) inventory management or controls to prevent mix ups during storage and distribution

Observation 6: Lack of Pest control and contamination control

Materials were kept in drums with damaged walls, open lids, with visible dirt and particles and bird droppings over the bags and drums. Multiple pests, animal sightings observed within the warehouse buildings – bird nests, birds flying throughout the warehouse buildings, crawling lizards and cats crawling between pallets of drums

The observation points to sad state of affairs at the warehouse facility which seems to be storing recovered, unaccounted and undocumented material from the FDA registered sites along with other materials. This raises questions not only about the material stored at the facility but also the operations and control of materials at other FDA registered facilities of the Firm. Regulatory guidance like ICH Q7A, clearly define the requirements of storage facilities, documentation and records of materials, labelling, material management, receipt, inspection, sampling and testing, quarantine, storage, recovery and reuse of materials. The USFDA 483 highlights how unsustainable and damaging it is to compromise and violate these fundamental GMPs.

• Hetero Undisclosed Warehouse – FDA 483 (September 2025)
• Hetero USFDA Form 483: Unregistered Testing Lab, Undocumented Warehouse (September 2025)