The FDA on Tuesday released a warning letter that it has issued to Mylan regarding quality-control deficiencies at the drugmaker's antiretroviral therapy manufacturing facility in Nashik, India. In the letter dated April 3, the agency noted that Mylan failed to adequately address problems that had been identified during a September 2016 inspection. "Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs you manufacture," the FDA stated.
Specifically, the FDA said Mylan did not thoroughly investigate unexplained discrepancies or the failure of batches to meet specifications. According to the agency, the company had invalidated 101 of 139 tests from January through June 2016 "without sufficient investigation to determine the root cause of the initial failure."
The agency also indicated that Mylan failed to establish an adequate quality-control unit that would review production records and ensure that any errors are fully investigated. Although Mylan showed inspectors "isolated examples of interrupted, missing, deleted and lost data" for which it had opened investigations, the company "attributed numerous incidents to power interruptions, connectivity problems and instrument malfunctions," the FDA said. The regulator added that Mylan "could not explain why these events occurred with frequency," nor did it launch a comprehensive investigation into the problem or seek to correct and prevent it.
"Until you correct all violations completely," the FDA warned that it could "withhold approval of any new applications or supplements listing [Mylan] as a drug manufacturer." Company spokeswoman Nina Devlin remarked that Mylan is "working closely with the FDA to respond to and address the issues raised in the letter as comprehensively and expeditiously as possible." She pointed out that "in the decade that Mylan has supplied [antiretroviral therapies], we have never had any supply disruption due non-compliance at any site and…we do not anticipate any supply disruption at this time."
Commenting on the news, Wells Fargo analyst David Maris suggested it was unclear what commercial impact the FDA warning could have on Mylan, if any, although "nothing is more critical for a brand or generic drug company than being able to ensure that its products are safe and effective," Maris said. Meanwhile, Evercore ISI analyst Umer Raffat remarked that the news is "not a biggie."
The FDA warning letter follows the recent expansion of a voluntary recall of Mylan's EpiPen (epinephrine) to include auto-injectors distributed in the US, in addition to other markets in Europe, Asia, North America and South America. The company, whose manufacturing partner for EpiPen is Pfizer's Meridian Medical Technologies unit, had initially recalled 81 000 devices distributed in Australia, New Zealand, Europe and Japan over a potential defect that could make the device difficult to activate in an emergency.
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