FDA 483 - Mylan Laboratories Limited

An FDA inspection conducted from June 14-26, 2024, at Mylan Laboratories Limited (FDF-3) in Pithampur, India, revealed significant deviations from current Good Manufacturing Practices (cGMP). The observations highlighted critical issues across several systems, including facility and equipment, quality, laboratory control, and production. Major violations in the facility and equipment system included inadequate cleaning procedures for non-dedicated manufacturing equipment, leading to confirmed cross-contamination of drug products. The firm also failed to report these potential contamination risks promptly and used deficient cleaning validation acceptance criteria and test procedures for swab analysis. The quality system exhibited inadequate investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results, with examples of aborted tests, unscientific root cause determinations, and "testing into compliance" practices. Laboratory controls were found deficient due to inadequate standard test procedures and inconsistencies with analytical method validations. Furthermore, the Quality Control unit demonstrated a lack of data integrity oversight, with instances of potential falsification of testing data and poor documentation practices. Computer systems also lacked appropriate controls, with uninvestigated audit trail breaches and excessive administrative access for QA personnel. Finally, the production system failed to calculate and document yield percentages for numerous U.S. market packaging batches. Mylan Laboratories Limited is required to provide a comprehensive response addressing each observation with detailed corrective and preventive actions to ensure compliance with regulatory standards.