FDA EIR - Unknown Company - August 12, 2022

An FDA unannounced, for-cause follow-up inspection of Hetero Labs Limited (Unit V) was conducted from August 4 to August 12, 2022. Operating under regulatory frameworks for drug manufacturing inspections and Field Alert Reports (FARs), this inspection served as a follow-up to a 2019 inspection and a 2017 Warning Letter. The inspection revealed six significant deficiencies, documented in an FDA-483 form. Key violations included the quality control unit's failure to fully follow procedures, incomplete investigations of drug complaints, and the lack of timely Field Alert Report submissions for failing drug batches. Furthermore, employees lacked adequate training for manufacturing functions, and written procedures for equipment cleaning and maintenance were not established. Inadequate controls over computer systems for critical record changes were also cited. These issues pointed to a systemic breakdown in the company’s quality system, with direct implications for product quality such as cross-contamination risks. The FDA classified the inspection as "Official Action Indicated (OAI)" and recommended a warning letter. The company committed to responding to the FDA-483 observations within 15 business days, necessitating comprehensive corrective actions.