FDA 483 - Mylan Laboratories Limited - September 23, 2022

Mylan Laboratories Limited's Hosur Sterile Facility received a Form 483 with six observations related to significant deficiencies in their manufacturing processes for sterile drug products. The inspection revealed issues with equipment performance, environmental monitoring, aseptic process validation, and quality control oversight. These findings indicate a lack of adherence to cGMPs, potentially compromising the sterility and quality of their drug products.