FDA 483 - Tianish Laboratories Private Limited - October 19, 2018

An FDA inspection of Mylan Laboratories Limited (Units 1/2) in Hyderabad, India, revealed a significant concern regarding the storage of raw materials and finished products. The firm failed to ensure appropriate temperature conditions, potentially affecting product identity, strength, quality, and purity. This was evidenced by inadequate temperature mapping studies and a lack of continuous temperature monitoring in key warehouses.