Washington: 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.
More than 80% of US drug ingredients are produced abroad, mainly in China and India. The FDA has stepped up oversight of overseas production facilities as concerns have arisen about safety and reporting procedures, and more than 40 factories in India have been banned from sending products to the US.
Mylan fell 1.9% to $38.51 at 11:21am in New York.
Mylan invalidated 101 out of 139 tests that showed from January through June 2016 that drug batches didn’t meet certain quality specifications, according to the FDA, which inspected the plant in September. The company didn’t investigate the reason for those failures, nor did it probe error signals that indicate lost or deleted quality data, the agency said.
In instances when it did investigate, Mylan often blamed the failing results on “power interruptions, connectivity problems (disconnection of the Ethernet or power cord), and instrument malfunctions,” according to the warning letter. Mylan retested the samples immediately after the interruptions, the FDA wrote.
Mylan is “working closely with FDA to respond to and address the issues raised in the letter as comprehensively and expeditiously as possible,” said Nina Devlin, a spokeswoman, in an email. The site continues to operate and is “in good standing with other global regulatory entities,” she said.
The drugmaker has hired a consultant to help it meet US requirements, the FDA said. The agency asked Mylan to conduct a detailed investigation of the extent of the inaccuracies and a risk assessment of the potential effects of the failures on the quality of the company’s drugs. The FDA said it could withhold approval of new drugs until it can confirm compliance with quality standards. Bloomberg