FDA 483 - Hetero Labs Limited - Unit III - July 21, 2023

An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, Telangana, India, a finished dosage drug manufacturer, revealed significant deficiencies in laboratory controls and quality systems. Observations included incomplete analytical data in laboratory records, lack of justification for LIMS changes, and insufficient raw data and impurity calculations. Additionally, the firm failed to maintain complete investigation records for unexplained discrepancies, leading to repeated deviations and ineffective corrective actions.