FDA 483 - Mankind Pharma Limited - January 11, 2019

An FDA inspection of Mankind Pharma Limited in Rampur Ghat, Himachal Pradesh, India, revealed a significant issue with the facility's plumbing system. The firm failed to detect leaks from its (b) (4) system, which could lead to contamination of drug products. This observation indicates a potential risk to product quality and patient safety.