Birds, Lizards, and Broken Protocols: USFDA Slams Hetero Labs Over Filthy Warehouse, Missing Records

The inspection, carried out between September 19 and 26, 2025, resulted in an FDA Form 483 issued to Mr. Naresh Reddy, Corporate Quality Assurance (CQA) Senior Manager, Hetero Labs Limited, detailing multiple critical violations.

Warehouse Denied Entry, Staff Fled from Inspectors

The report begins with a striking observation:

“Upon arrival for inspection, entry was denied for approximately two (2) hours to inspect the warehouse that holds key starting materials, intermediates, and finished APIs for US FDA registered manufacturing facilities… Employee personnel, who were later identified as the Assistant Warehouse Manager and Warehouse Staff, had ran out of plain sight upon announcing our intent to inspect the facility.”

FDA investigators noted that warehouse gates were abruptly shut and access was blocked for nearly two hours. A truck full of drums was seen at the loading dock but was driven away once the inspectors arrived, with another incoming truck turned back by security.

“The truck full of drums had left the facility without any explanation provided,” the report stated.

Undisclosed Warehouse with US-Linked Stock

The agency observed that the warehouse was “undisclosed with the U.S. FDA” despite holding APIs and intermediates destined for the American market.

“Your facility is a warehouse that is undisclosed with the U.S. FDA… You failed to document the incoming receipt of these materials and perform a visual examination to ensure correct and complete labeling.”

The inspectors documented Hetero Unit IX-labeled drums, including defaced, handwritten, and partially torn labels, with no traceability or quality documentation. In one instance, recovery material was stored in drums labeled for an entirely different batch — a major traceability breach.

“There is no documentation for the practice of defacing, cutting, and replacing original Hetero Unit IX drum labels with handwritten labels that do not include indication of the manufacturer name, customer's name, required storage conditions and grade designation,” the Form 483 noted.

No Quality Oversight, No SOPs, No Records

Perhaps most concerning, the FDA reported “no quality unit oversight” at the facility.

“The facility operates without any written Standard Operating Procedures (SOPs). For example, there are no SOPs governing receipt, storage, and distribution of APIs, environmental monitoring, handling of cold storage products, deviations, potential complaints, or recalls.”

Officials at the site reportedly admitted that no transportation logs, training records, or batch tracking systems existed. Even the Corporate Quality Assurance Manager told FDA officials that he was “unaware of the practices and operations concerning APIs, intermediates, and raw materials” at the warehouse.

Birds, Lizards, and Cats Found Among API Drums

In one of the most damning observations, the FDA documented pest infestations and open environmental exposure inside both warehouse buildings.

“Multiple pest and animal sightings were observed within the two buildings of the warehouse. This included birds flying throughout the warehouse buildings, bird droppings on top of drums, birds’ nest observed within the top seams of the warehouse, crawling lizards, and cats crawling in between pallets and rows of API and Intermediate drums.”

The agency added that several drums were found damaged, open to the environment, and stored near bird nests and droppings, with no system for pest control or container inspection.

Expired Materials Mixed with New Batches

Inspectors also found expired products commingled with fresh batches.

“Expired drums being commingled with recently dated 2025 material drums within the warehouse facility… There is no procedure for segregation or quarantine of rejected, released, or quarantined material.”

This mix-up risk was further compounded by the absence of FIFO (first-in, first-out) inventory management and lack of any quarantine system.

Uncontrolled Environment, No Temperature or Humidity Monitoring

The FDA noted the absence of environmental controls, stating:

“There is no system or mechanism for monitoring temperature and humidity for APIs, intermediates, key starting materials, and raw materials stored throughout the warehouse. The buildings are open to the outside environment.”

The inspection also revealed that certificates of analysis (CoAs) for stored materials were not available on-site, violating basic traceability norms.

Regulatory Implications

The Form 483 observations indicate potential violations of 21 CFR Part 211, which governs GMP for finished pharmaceuticals. Such findings often precede Warning Letters or import alerts, depending on the company’s response and corrective action.

Hetero Labs is one of India’s largest API and finished drug manufacturers supplying global markets, including the U.S. A pattern of regulatory scrutiny could have broad implications for its global supply operations.

The inspection’s imagery — birds flying over API drums, lizards and cats crawling between pallets, handwritten labels, and undocumented shipments — paints a disturbing picture of non-compliance at a site linked to U.S.-regulated products.

The FDA concluded that the “balance of convenience and irreparable harm” lies in immediate corrective action, calling on the firm to establish proper GMP oversight, documentation, and pest control protocols to prevent contamination and safeguard patient safety.