Shares of Epipen manufacturer Mylan dropped Tuesday afternoon following the release of a letter to the firm from the U.S. Food and Drug Administration, which raised concerns about quality controls at one of Mylan’s manufacturing plants in India.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the FDA said in its letter to Mylan. These conclusions were drawn after the FDA launched an investigation into Mylan’s Nashik facility, the group said.
