FDA 483 - Tianish Laboratories Private Limited - September 13, 2022

An FDA inspection of Mylan Laboratories Limited – Unit 7, an API manufacturer in Patancheru, India, revealed significant deficiencies, including a repeat observation for failure to validate analytical test methods for APIs and intermediates. The firm also failed to adequately clean and maintain equipment, had an inadequate procedure for investigating critical quality events, and conducted a flawed cleaning validation study. These issues indicate a lack of control over manufacturing processes and quality systems.