Mylan Laboratories Limited (FDF-2) – FDA 483, Aug 25, 2026

Mylan Laboratories Limited (FDF-2) in Chhatrapati Sambhajinagar, India, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. The inspection revealed critical failures including inadequate investigations into out-of-specification results and delayed product recalls, widespread data integrity issues in laboratory and batch records, and poor equipment cleaning practices. These findings indicate a severe lack of control over drug product quality and a high risk of non-conforming products reaching the U.S. market.