FDA hits Mylan’s Indian plants with warning letter
pharmafile | August 20, 2015 | News story | Manufacturing and Production | Contamination, FDA, Mylan, Pfizer, manufacturing, production
The FDA has served Mylan with a warning letter citing contamination at three of its manufacturing facilities in India.
Inspections carried out by the FDA in February, August and September 2014 revealed a lack of protection against contamination and batch failures at the sites in Bangalore.
In its warning letter the FDA says: “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. Furthermore, several violations are recurrent and long-standing.”
Two of the sites were acquired in Mylan’s $1.75 billion deal for Agila Specialties in 2013, which according to the FDA already had issues with contamination.
The FDA noted the three plants raised serious contamination concerns, such as the quality of the gloves employees used in sterile areas, which inspectors said often had pin holes that could lead to direct exposure.
In response to the letter, Mylan’s chief executive Heather Bresch comments: “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. 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 is still occupied with its lengthy £34 billion takeover of Perrigo, a manufacturer of private label over-the-counter (OTC) drugs. It is thought that Mylan investors will vote on the acquisition of Perrigo on August 28th 2015 in order to come to a final decision.
Yasmita Kumar
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