Mylan sees three Indian plants under FDA scanner on quality

Three Mylan-run drug manufacturing operations in India have been cited in a U.S. FDA warning letter for quality violations that included a failure to set procedures aimed at preventing microbiological contamination and on the use of torn gloves.

Mylan CEO Heather Bresch

The issues, highlighted in the warning letter and press reports, brought a swift response from Mylan ($MYL) that saw CEO Heather Bresch comment about the units acquired in 2013 for $1.75 billion from India's Strides Arcolab. The units covered in the letter are the Agila Specialty Formulation Facility, Sterile Product Division, and Onco Therapies Limited.

"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," Bresch said in an Aug. 18 statement.

"As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate," Bresch said in the statement. "We have been and will continue to work diligently to address all of the FDA's observations and have made important progress."

The violations outlined in an Aug. 6 warning letter come as Mylan attempts to close a potential $33 billion acquisition of Perrigo ($PRGO) with its own shareholders scheduled to vote on Aug. 28, Bloomberg said, and as domestic manufacturers and CROs in India face repeated questions and sanctions for failure to ensure quality and safety in testing and manufacture.

- here's the FDA warning letter
- and Mylan's statement
- plus a Bloomberg story in India's LiveMint