|
 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.
http://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 said.
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.
[to top of second column] |
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," Devlin said.
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 Sachin
Ravikumar)
[© 2017 Thomson Reuters. All rights
reserved.] Copyright 2017 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
