Sep 3, 2020 2 min read

Mylan NV has received a warning letter from the U.S. Food and Drug Administration, saying the company did not do its best to ensure the safety of pharmaceutical ingredients at a manufacturing plant in India.

The FDA sent the missive to Heather Bresch, Mylan’s chief executive officer, Aug. 20. The letter says it “summarizes significant deviations from current good manufacturing practice for active pharmaceutical ingredients” to ensure against contamination.

The agency said it uncovered issues following an inspection Feb. 24-28 at the Mylan Laboratories Ltd. Unit 7 facility in Sangareddy, India. The FDA said it was concerned about a lack of cleaning records before October 2019 and quality control.

Mylan, which has corporate headquarters in Cecil Township but is incorporated in the Netherlands, said it will respond formally to the FDA within 15 days.

The company said in a statement that the inspection “placed a primary focus on nitrosamine or any similar impurities.”

Nitrosamine is a chemical limited by the FDA for use in medications. It also is a carcinogen.

Mylan said that “several months prior to the inspection, we put additional controls, corrective actions and improvements in place at the Unit 7 facility to mitigate any perceived risk of product contamination with patient safety as our primary focus.

“Importantly, extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified.”

The company added that it “is committed to maintaining the highest quality manufacturing standards at all of its facilities around the world. We have an industry-leading track record in global quality management, and we take very seriously continued and comprehensive oversight of Mylan’s entire manufacturing network.”