FDA 483 - Mylan Laboratories Limited - September 17, 2021

Mylan Laboratories Limited in Hosur, India, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, insufficient validation of aseptic processes, poor employee aseptic techniques, and issues with equipment maintenance and air control systems. These findings indicate a lack of robust controls to ensure sterility assurance for drug products.