Mylan gets FDA warning on drug quality at factory in India
The FDA said it could withhold approval of new drugs until it can confirm compliance with quality standards. Photo: Getty Images/AFP
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 US drug regulator said.
The quality system at Mylan’s facility in Maharashtra, India, “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the Food and Drug Administration told the company in a warning letter dated 3 April that was posted Tuesday.
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