FDA 483 - Tianish Laboratories Private Limited - December 10, 2018

Mylan Laboratories Limited (Unit 8) in G. Chodavaram Village, India, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately investigate unexpected results, including impurities and unknown peaks, and exhibited poor maintenance and cleanliness in its manufacturing facilities. Additionally, analytical methods used for drug substance testing were not consistent with validated conditions.