FDA EIR - Mylan Laboratories Limited - June 26, 2024

An unannounced FDA inspection of Mylan Laboratories Limited, located in Pithampur, India, was conducted from June 14 to June 26, 2024. This inspection focused on the company's current Good Manufacturing Practice (cGMP) status for drug products intended for the USA market, following the regulatory framework for drug manufacturing. The inspection revealed six significant observations documented on Form FDA 483. Key issues included inadequate cleaning intervals for equipment and utensils, and a failure to thoroughly investigate unexplained discrepancies or batch failures. Furthermore, the company's laboratory controls lacked scientifically sound sampling plans and test procedures to ensure product quality and purity. Deficiencies were also noted in the quality control unit's adherence to established procedures, and there was insufficient control over computer systems to restrict changes to authorized personnel. Finally, the company failed to determine actual and theoretical yields at appropriate manufacturing phases. These findings indicate a deviation from regulatory expectations for pharmaceutical manufacturing. Mylan's management committed to addressing these observations and providing a written response within 15 business days. The FDA classified this inspection as Official Action Indicated (OAI) and recommended the issuance of a Warning Letter, signifying serious concerns requiring comprehensive corrective actions.