A view shows the U.S. Food and Drug Administration headquarters in Silver Spring Maryland
Cris De Lacerda
12 Abril, 2017, 20:10
The letter highlights the FDA's increased scrutiny on overseas production facilities in recent years, especially in India and China, where more than 80 percent of ingredients used in the usa drugs are produced.
The agency concluded that: "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". US 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".
"Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer", the regulatory group wrote in its note published Tuesday.
And in this latest warning letter, FDA cautions that Mylan has not identified trends in its out-of-specification (OOS) investigations, which is a repeat observation from a March 2015 inspection. These conclusions were drawn after the FDA launched an investigation into Mylan's Nashik facility, the group said.
The firm added: "As FDA standards for our industry continue to evolve, we are dedicated to continually enhancing our systems and processes with a deliberate, thorough approach to assure sustainable quality across our entire network of facilities". Production is ongoing and Mylan doesn't expect any supply issues related to products being manufactured at the India site, Mylan said.
The Nashik, India, facility is just one of Mylan's 50 manufacturing sites across the globe with 24 focused on oral solid doses.
Mylan's stock fell more than 2 percent following this news Tuesday afternoon and is down almost 16 percent over the past year.
Before the FDA inspection, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom inspected the India facility and said Mylan met the good manufacturing practice minimum standard.