Mylan Laboratories Limited – FDA 483, May 17, 2024

Mylan Laboratories Limited, a sterile drug manufacturer in Hosur, India, was inspected and cited for significant deficiencies in aseptic processing, cleaning validation, and quality control. Observations included inadequate cleaning and disinfection systems, insufficient aseptic process validation, failure to investigate recurring microbial contamination, and non-compliance with Field Alert Report requirements. These issues indicate a high risk to the sterility and quality of drug products.