The FDA inspections from February and earlier in 2014 revealed a lack of protection against contamination and batch failures.
“These items found at three different sites, together with other deficiencies found by our investigators, raise questions about the ability of your current corporate quality system to achieve overall compliance with CGMP [current good manufacturing practice],” the FDA said.
Two of the plants cited by the FDA were acquired in Mylan’s 2013 acquisition of Agila Specialties, a unit of Strides Arcolab, which had problems of its own with contamination problems in recent years.
At the Mylan site, FDA found “gloves used for aseptic processing had tears and pin holes,” which is a particular problem for a facility that is supposed to be designed to prevent microbiological contamination of drug products purporting to be sterile. The agency also said there’s a lack of assurance that Mylan maintains its manufacturing environment in a state that’s suitable for aseptic processing.
The FDA also tells Mylan that the evaluation of environmental microbial data “should not be narrowly limited to specific lots or events. Trend analysis, identifying sources of contamination, and risk assessment are essential to maintain adequate microbiological control.”
Mylan CEO Heather Bresch said in a statement: "Since Mylan acquired the Agila injectables businesses inDecember 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…As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate. We have been and will continue to work diligently to address all of the FDA's observations and have made important progress."
Mylan investors will vote on the Perrigo acquisition Aug. 28.