FDA 483 - Mylan Laboratories Limited - February 07, 2020

An FDA inspection of Mylan Laboratories Limited in Sinnar, India, revealed significant deficiencies in their quality control unit, including failures to investigate product-impacting alarms and trend defects. The firm also failed to thoroughly investigate unexplained discrepancies and batch failures, leading to the release of out-of-specification products. Furthermore, a repeat observation highlighted inadequate training and qualification for visual inspectors, raising concerns about product quality assurance.