Mylan, Critic of Indian Drugmakers, Warned by FDA on Quality

Mylan NV, one of the generic drug industry’s biggest critics of poor quality at Indian drugmakers, had “significant violations” of manufacturing-quality rules at three plants in India, U.S. regulators said in a warning letter.

The violations include failure to establish and follow written procedures to prevent microbiological contamination, use of torn gloves, poor monitoring to ensure a contamination-free environment and a failure to investigate product complaints, according to the warning letter from the Food and Drug Administration dated Aug. 6.