(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3.
India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of key suppliers to the U.S.
“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 says in the letter to Mylan.
The agency’s concerns stem from an inspection in September of a facility located at Nashik in the western Indian state of Maharashtra that produces antiretroviral therapies (ARVs) used to treat HIV.
“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 analyst David Maris says.
The FDA outlines several violations at Mylan’s Nashik facility, including a failure to “thoroughly investigate” unexplained discrepancies in drug batches and cited examples of “missing, deleted, and lost data”.
The agency says Mylan had opened an investigation into the lost data, but attributed it to power interruptions, connectivity problems and instrument malfunctions.
“You could not explain why these events occurred with frequency in your laboratory, nor had you undertaken a comprehensive investigation into the problem or sought to correct it and prevent its recurrence,” the FDA writes.
Until the regulator can confirm Mylan’s compliance with standard manufacturing practices, it may withhold approval of any new applications listing the firm as a drug manufacturer, the FDA says.
Mylan has nine independent sites, including the Nashik facility, that produce and supply ARVs, which helps maintain continuous supply, Mylan spokeswoman Nina Devlin tells Reuters.
“In the decade that Mylan has supplied ARVs, we have never had any supply disruption due non-compliance at any site and, again, we do not anticipate any supply disruption at this time,” Devlin say.
In 2015, the FDA sent a warning letter expressing concerns over quality controls at three Mylan facilities in the south Indian city of Bengaluru.
