US FDA Slams Hetero Labs After Inspectors Find Birds, Lizards & Filthy Conditions In Warehouse | India News
Last Updated:November 01, 2025, 12:13 IST The 8-page report listed six major observations, concluding that the warehouse was operating outside fundamental Good Manufacturing Practice (GMP) requirements The FDA also found that the warehouse had no designated quality unit, no standard operating procedures, and no environmental controls. (AFP) 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 …

