FDA 483 - Mylan Laboratories Limited - May 24, 2024

Mylan Laboratories Limited in Sinnar, India, was inspected and found to have significant deficiencies across its quality system, including inadequate investigation practices, poor documentation control, and facility maintenance issues. The firm failed to properly document investigation addendums and Global Quality Investigations Team (GQI) feedback, and its equipment and facility showed signs of disrepair and contamination risks. Additionally, the firm did not readily provide requested records, impeding the inspection.