| April 11
April 11 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 United States.
"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 said in the
letter to Mylan. bit.ly/2p2bKGV
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
The FDA outlined 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 said 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 wrote.
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 said.
Mylan has nine independent sites, including the Nashik
facility, that produce and supply ARVs, which helps maintain
continuous supply, Mylan spokeswoman Nina Devlin told 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,"
The FDA had in 2015 had sent a warning letter expressing
concerns over quality controls at three Mylan facilities in the
south Indian city of Bengaluru.
Mylan's shares were down 1.9 percent at $38.50 in afternoon
trading on the Nasdaq.
(Reporting by Natalie Grover in Bengaluru; Editing by Sai