Hetero Labs Limited (Unit V) – FDA 483, Aug 7, 2026

Hetero Labs Limited (Unit V) in Mahabubnagar, India, was cited for significant deficiencies in drug manufacturing practices during an FDA inspection. The firm failed to establish adequate process controls and validation for drug products, neglected to properly test raw materials, and maintained equipment in a condition that could lead to contamination. These issues indicate a lack of control over critical aspects of drug product quality and purity.