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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200

DRUG GIANT MYLAN GETS FDA WARNING LETTER

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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.

Drugmaker Mylan NV failed to investigate why medications made at a factory in India didn’t meet quality standards and frequently didn’t report the substandard results from its tests, the U.S. drug regulator said.  The quality system at Mylan’s facility in India, “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the FDA told the company in the warning letter dated April 3. The warning letter stated that Mylan had 15 working days to respond by outlining corrective measures.

The agency ordered Mylan to go back and document all of the missing data and figure out what impact those failed tests may have had on its drugs.  It said the company needs a corrective action plan to deal with the issue so it is not repeated going forward.  Problems with data integrity have plagued many Indian  drugmakers, like Sun Pharma  and Wockhardt,  resulting in  an avalanche of FDA warning letters in the last few years.

The letter highlights the FDA’s increased scrutiny on overseas production facilities in recent years, especially in India and China, where more than 80 percent of ingredients used in the U.S. drugs are produced.  The agency stepped up its oversight as concerns have arisen about safety and reporting procedures, banning more than 40 factories in India from sending products to the U.S.

“We are working closely with the FDA to respond to and address the issues raised in the letter as comprehensively and expeditiously as possible,” a Mylan  spokesperson wrote via email.  “Mylan has always had a deep and unwavering commitment to quality everywhere we operate.”