Mylan Gets Warning Letter Over Cancer Drug Recalls

Federal drug regulators say they will refuse to accept any applications for new or generic drugs from three Mylan Parmaceuticals manufacturing facilities linked to recent cancer drug recalls, until a number of problems discovered by inspectors are resolved. 

The FDA sent a warning letter to Mylan on August 6, following inspections last year and earlier this year at three recently-acquired plants in Bangalore, India.

The plants, which Mylan acquired from Agila in December 2013, were linked to the recall of several injectable cancer drugs, including gemcitabine, carboplatin, methotrexate, and cytarabine, earlier this year.

The Mylan cancer drug recall was first announced in April, due to the presence of visible particulate matter floating in the injections. The recall was expanded in June to a total of eight lots.

Mylan officials have said that the plants were only recently acquired and it is working on bringing them up to par. However, FDA investigators said many of the issues should have been addressed by now.

FDA inspectors found a wide range of issues that could lead to contaminated products, including glove quality, bad microbial testing results, uninvestigated customer complaints, and vials of the drugs that were rejected with no written explanation.

“At all three sites, we identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals,” the FDA letter states. “Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.”

Mylan responded to the warning letter with a press release issued on Tuesday.

“Since mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan’s One Quality Standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term,” Mylan CEO Heather Bresch said in the statement. “As part of this ongoing process, we have a deep and unwavering commitment to quality everwhere we operate. We have been and will continue to work diligently to address all of the FDA’s observations and have made important progress.”

The FDA acknowledged that the company responded to FDA concerns in August and October of 2014, and again in March of this year, but noted that the responses lacked sufficient corrective actions.

The FDA said that until the problems are properly addressed, the plants will be unable to file new or generic drug applications from the facilities.