FDA 483 - Mylan Laboratories Limited - May 27, 2022

An FDA inspection of Mylan Laboratories Limited, a sterile manufacturer in Anekal Taluk, Bangalore, Karnataka, India, identified significant deficiencies. The firm's sampling process for in-process and semi-finished products was found inadequate, failing to ensure representative sterility samples under critical conditions. Furthermore, laboratory controls lacked scientifically sound analytical test procedures, impacting the quality assurance of US-marketed sterile injectable products.