FDA EIR - Hetero Labs Limited - August 12, 2022

An FDA inspection of Hetero Labs Limited (Unit V), a finished drug product manufacturer in Polepally Village, Mahabubnagar, was conducted from August 4 to August 12, 2022. This unannounced, for-cause follow-up inspection, under Drug Manufacturing and Field Alert Report compliance programs, identified significant compliance deficiencies. The inspection resulted in six observations detailed on Form FDA-483. Key issues included the quality control unit not fully adhering to its responsibilities, inadequate documentation of drug complaint investigations, and a failure to submit Field Alert Reports within the required timeframe for out-of-specification drug batches. Additionally, employees lacked adequate training for manufacturing functions, written procedures for equipment cleaning and maintenance were not established or followed, and computer system controls were insufficient to ensure only authorized personnel made changes to master records. This follows previous regulatory actions, including a 2017 Warning Letter. The current findings led to an "Official Action Indicated" classification, with the FDA recommending a warning letter, signaling a breakdown in the quality system. The company's Vice President of Operations acknowledged the observations and committed to providing a response within 15 business days. Significant comprehensive corrective actions are now required to address these systemic quality failures and prevent further regulatory action.