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Mylan Warned by FDA Over India Drug Plant’s Quality Controls (2)

Sept. 1, 2020, 5:52 PM

Mylan NV received a warning from U.S. regulators for failing to ensure key drug ingredients made at one of its plants in India were not contaminated.

The Food and Drug Administration recommended Mylan Chief Executive Officer Heather Bresch hire a consultant to help the generic drugmaker improve its manufacturing practices, according to an Aug. 20 warning letter released Tuesday. Mylan’s share fell 5% to $15.55 at 1:44 p.m. in New York.

The FDA inspected Mylan’s facility in Pashamylaram, India, in February. The agency found the plant, which makes active ingredients for drugs, hadn’t taken the proper precautions to ensure solvents ...