FDA 483 - Hetero Labs Limited (Unit V) - August 12, 2022

An FDA inspection of Hetero Labs Limited (Unit V) in Mahabubnagar, India, a finished dosage manufacturer, revealed significant deficiencies in its quality control unit, including inadequate cleaning validation, process capability assessments, and laboratory investigations. The firm also failed to properly investigate drug complaints, submit a required field alert report, ensure adequate employee training, maintain equipment cleanliness, and implement appropriate computer system controls. These observations indicate a broad range of issues impacting product quality and regulatory compliance.