FDA 483 - Tianish Laboratories Private Limited - February 28, 2020

Mylan Laboratories Ltd. - Unit 7, an API manufacturer in Hyderabad, India, was cited for significant deficiencies in its quality systems. Observations included inadequate cleaning validation, lack of solvent traceability, insufficient raw material testing for impurities, unvalidated laboratory test methods, and poor supplier evaluation for solvent recovery vendors. These issues indicate a systemic failure to ensure the quality and purity of APIs and intermediates.