Newspaper article Pittsburgh Post-Gazette (Pittsburgh, PA)

FDA Cites Mylan after India Plant Inspections

Newspaper article Pittsburgh Post-Gazette (Pittsburgh, PA)

FDA Cites Mylan after India Plant Inspections

Article excerpt

The U.S. Food and Drug Administration has cited local generic drug giant Mylan for "significant violations" of manufacturing regulations at a plant in Nashik, India, according to a warning letter released by the agency Tuesday.

The FDA conducted inspections at the plant from Sept. 5-14 last year.

Among the problems cited in the letter, which listed concerns about quality controls, was invalidating out-of-specification results "without sufficient investigation."

The letter termed Mylan's earlier response to the agency's initial findings "inadequate."

"When something reaches a warning letter stage, it can show that the FDA is dissatisfied with the company's attempts to explain or remediate the issue," Wells Fargo Securities analyst David Maris wrote in a note to clients. …

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