FDA 483 - Mylan Laboratories Limited - May 24, 2024

An FDA inspection conducted from May 13-24, 2024, at Mylan Laboratories Limited in Sinnar, Maharashtra, India, revealed significant deficiencies in the firm's quality systems and manufacturing practices. The inspection, documented in an FDA Form 483, identified seven main observations related to current Good Manufacturing Practices (cGMP). Key issues include a lack of adequate control and documentation within the quality control unit, specifically concerning investigation addendums, Corrective and Preventive Actions (CAPAs), and proper control over laboratory worksheets. Investigations into unexplained discrepancies, such as out-of-specification (OOS) and out-of-trend (OOT) results, were found to be scientifically unsound, lacking comprehensive root cause analyses. Critical feedback from the Global Quality Investigation team was often communicated via undocumented email exchanges, undermining data integrity. A repeat deficiency from a 2016 inspection highlighted persistent issues with incomplete chromatographic data. Further concerns included the distribution of drug product batches containing foreign particles that were not adequately investigated for internal contamination. The facility also failed to maintain appropriate test procedures for dissolution testing and exhibited poor equipment and facility maintenance, with observed foreign material on product contact surfaces, damaged equipment, and compromised flooring in production areas, posing contamination risks. Finally, the firm initially withheld email communications related to critical quality event investigations, obstructing the inspection process and raising serious questions about record availability and transparency. Mylan Laboratories Limited is required to promptly address these observations with comprehensive corrective and preventive actions to ensure full compliance with cGMP regulations and safeguard drug product quality.