FDA EIR - Hetero Labs Limited - March 14, 2017

An FDA inspection of Hetero Labs Limited, located in Sanga Reddy District, Telangana, India, was conducted from March 6 to March 14, 2017. The inspection, a post-approval and comprehensive systems-based Good Manufacturing Practice (GMP) review, utilized guidance from ICH Q7A and focused on the manufacturing of active pharmaceutical ingredients (APIs). Key systems evaluated included Quality, Production, Materials, Facilities and Equipment, Laboratory, and Packaging and Labeling. Notably, at the conclusion of the inspection, no FDA Form 483, "Inspectional Observations," was issued, indicating no significant deficiencies were identified. Two verbal observations were discussed with management. One such observation related to a minor procedural deviation concerning the timing of preventive maintenance activities, where work was completed ahead of schedule, not fully aligning with the firm's documented procedure at that time. However, the FDA investigator determined no immediate adverse quality impact from this isolated instance. Management was cooperative throughout the inspection. No samples were collected, and no refusals were encountered. This positive outcome aligns with the company's previous inspection in 2013, which also resulted in no FDA 483 and a "No Action Indicated" classification.