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Viatris, Inc.'s Mylan Laboratories Limited facility in India failed to maintain Current Good Manufacturing Practice (CGMP) standards for finished pharmaceutical drugs, resulting in adulterated drug products. FDA inspectors identified critical data integrity failures in the quality control unit, specifically finding that analysts documented component identification test results as passing while biometric records proved they were not physically present at the facility during testing. The firm lacked adequate written procedures and controls to ensure the reliability of quality control data throughout the CGMP data lifecycle, violating 21 CFR 211.22(d) requirements for quality control responsibilities.