FDA 483 - Hetero Labs Limited - Unit III - June 07, 2019

Hetero Labs, Ltd. - Unit III, a finished dosage drug manufacturer in Hyderabad, India, was cited for significant deficiencies across its quality systems. The inspection revealed widespread issues including inadequate computer system controls, lack of written procedures for critical manufacturing processes, insufficient investigations into discrepancies, and failures in laboratory instrument calibration and sample management. These observations indicate a systemic lack of control over manufacturing and quality operations, posing a high risk to product quality and data integrity.