FDA cites Mylan after India plant inspections
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.
Mylan, which runs its administrative functions out of Cecil, did not respond to emails Tuesday seeking comment.
In an email to Bloomberg business news, the company said it was “working closely with the FDA to respond to and address the issues raised in the letter as comprehensively and expeditiously as possible.”
The plant continues to operate and is “in good standing with other global regulatory entities,” the email said.
The warning letter, dated April 3, stated that Mylan had 15 working days to respond by outlining corrective measures.
“Until you correct all violations completely” the FDA could withhold approval of new drug applications and block products from coming into the U.S., the letter said.