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Flying birds, skittering lizards and roaming cats—these were among a host of serious violations flagged by the American health watchdog at Hetero Labs’ drug-making unit in India, which exports medicines to the US market. In a scathing Form 483 report, seen by News18, the US Food and Drug Administration (FDA) slammed the Indian generic drugmaker after inspectors uncovered filthy and poorly controlled conditions at the facility. According to a Form 483 issued on September 26, FDA investigators said access to the warehouse storing active pharmaceutical ingredients (APIs), intermediates, and key starting materials (KSMs) intended for the US market and its associated records was “not made readily available for inspection”. Hyderabad-based Hetero Labs is one of India’s largest API and generic drug producers. During the inspection, according to the US FDA’s report, “the assistant warehouse manager and assistant vice president of warehouse stated that the warehouse is only used to store materials for Hetero Unit Ill facility, which solely distributes to the Indian domestic market”. News18 has reached out to Hetero for a response via email and is awaiting a response. Uncovering Series Of Lapses The report described how inspectors were refused entry for approximately two hours, during which “a truck full of drums had left the facility without any explanation provided”, and another incoming truck “was turned away by the security officers upon their indicating our presence at the facility”. Once inside, investigators found multiple signs of contamination, animal activity and labelling irregularities. The FDA said “multiple drums containing intermediates were observed to have damage to the drum walls and open lids,” with “visible dirt particles observed throughout the top of the bag.” The agency also documented “multiple pest and animal sightings” within the two buildings of the warehouse, including “birds flying throughout the warehouse buildings, bird droppings on top of drums, birds’ nests observed within the top seams of the warehouse, crawling lizards, and cats crawling in between pallets and rows of API and intermediate drums.” The inspection team said the facility “is a warehouse that is undisclosed with the US FDA” but was found holding active pharmaceutical ingredients (APIs), intermediates and key starting materials (KSMs) for FDA-registered manufacturing sites. Investigators noted that drums from another Hetero site were being stored at the warehouse without records, some bearing “defaced and/or partially torn Hetero Unit IX labels” or handwritten tags missing key information such as manufacturer name and required storage conditions. The FDA also found that the warehouse had no designated quality unit, no standard operating procedures, and no environmental controls. The report said there were no standard operating protocols (SOPs) governing “receipt, storage, and distribution of APIs, Intermediates, and raw materials,” nor any for “handling of potential complaints and recalls”. In another striking observation, the agency noted that expired 2021 material drums were stored adjacent to 2025-approved batches, with no segregation or inventory control. “There is a failure to establish adequate controls to prevent mix-ups during storage and distribution operations,” the report stated. Investigators added that the facility lacked temperature and humidity monitoring systems, even for materials requiring controlled storage between 2°C and 8°C. “There is no procedure for handling and monitoring KSMs, and intermediates stored within the cooler,” the FDA said. The 8-page report listed six major observations, concluding that the warehouse was operating outside fundamental Good Manufacturing Practice (GMP) requirements. It also recorded that Hetero’s own corporate quality assurance head visited the site during the inspection and admitted he was “unaware of the practices and operations concerning the warehouse”. Form 483 observations are preliminary findings and do not represent the FDA’s final determination. However, companies are expected to respond within 15 working days, outlining corrective measures.
