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Pharmaceuticals / Quality / Inspections and Audits

FDA Issues 14-Page Warning Letter to Mylan Over Three India Plants

Aug. 26, 2015

The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013.

The concerns, chronicled in a 14-page warning letter, include lapses in clean-room practices and environmental monitoring that were the subject of a September 2013 warning letter to Agila. Since Mylan was aware of that letter, it should have taken steps to correct the problems, the agency says.

The latest warning stems from inspections in 2014 and early this year at Onco Therapies Limited, Specialty Formulation Facility and Sterile Product Division, all located in Anekal Taluk, Bangalore.

During a February inspection of the OTL site, investigators observed clean-room employees wearing torn gloves, gowns and booties and entering restricted areas without sanitizing gloved hands, the Aug. 6 warning letter says. Similar issues were found at the other two sites.

Meanwhile, the SFF site was cited for inadequate media fill studies, as vials were rejected without cause and not incubated. During a fall 2014 inspection of that facility, investigators found 456,201 alarmed events for differential air pressures and 16,415 for particulates recorded over multiple month periods — leading them to conclude that the plant’s building management and nonviable particle monitoring systems are “out of control.”

The third site, SPD, failed to thoroughly investigate unexplained batch failures and discrepancies. After receiving two complaints about discolored injectables in 2012, employees investigating the incidents didn’t include evidence to support the cause and didn’t check other products manufactured with the same equipment. The August 2014 inspection also revealed that two cases of defect-related adverse events weren’t investigated.

Mylan CEO Heather Bresch said the company is working to address the concerns. The drugmaker halted production and distribution at the OTL site in March.

View the warning letter at www.fdanews.com/08-20-15-MylanWarning.pdf. — Kellen Owings