FDA 483 - Tianish Laboratories Private Limited - March 16, 2018

An FDA inspection of Mylan Laboratories Limited (Units 1/2) in Medak District, Hyderabad, an Active Pharmaceutical Ingredients Manufacturer, revealed significant deficiencies across multiple systems. The firm failed to adequately investigate out-of-specification results, maintain proper quality unit oversight for CAPAs and change controls, ensure facility and equipment were in a state of repair, and provide sufficient employee training. These issues indicate a broad lack of adherence to established procedures and GMP requirements.