FDA EIR - Unknown Company - June 26, 2024

An unannounced FDA Good Manufacturing Practice (GMP) inspection of Mylan Laboratories Limited (FDF-3) in Pithampur, India, was conducted from June 14 to June 26, 2024. This inspection, focusing on the firm's current cGMP status for manufacturing drug products distributed in the USA, followed compliance program CPGM 7356.002 (Drug Manufacturing Inspection). The inspection revealed significant issues, leading to a six-item FDA Form 483. Main violations included inadequate cleaning of equipment, failure to thoroughly review unexplained discrepancies or out-of-specification batches, and insufficient laboratory controls for sampling and testing. Additionally, the quality control unit's procedures were not fully followed, appropriate controls over computer systems for record changes were lacking, and actual/theoretical yields were not determined at the conclusion of manufacturing phases. Based on these findings, the inspection was classified as Official Action Indicated (OAI), with a recommendation for a Warning Letter. Mylan Laboratories Limited's management committed to addressing the observations and submitting a written response within 15 business days.