The U.S. Food and Drug Administration has issued a warning letter to Mylan for “significant deviations from current good manufacturing practice” in the making of active pharmaceutical ingredients at the company’s plant in Sangareddy District, India.
The federal agency expressed concerns about Mylan’s lack of cleaning records and inadequate quality control for certain manufacturing and storage equipment.
Mylan, the FDA alleged, did not do a sufficient job testing all incoming raw materials to ensure they are suitable for the manufacturing process, didn’t have adequate procedures for detecting impurities, which, coupled with using non-dedicated equipment, created the risk of contaminating the ingredients that go into Mylan’s medicines.
This is the second warning letter for similar issues at a Mylan facility in the past year. In November, Mylan was cited for a different unit, in Andhra Pradesh, India.
“These repeated failures at multiple sites manufacturing [active pharmaceutical ingredients] demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the FDA letter said. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”
The agency again “strongly recommended engaging a consultant qualified to evaluate” Mylan’s operations.
Mylan, in a statement, said it does not anticipate any interruption in manufacturing or distribution as result of the warning letter.
“No significant commercial impact is expected and and no significant launches are planned for Unit 7 in 2020,” the company said, referring to the Sangareddy facility in late February.
The drugmaker, which is incorporated in the Netherlands but maintains a corporate headquarters in Cecil, said the FDA’s primary concern was nitrosamine and similar impurities that can form during drug processing and are thought to be possible carcinogens.
“Extensive testing of [active pharmaceutical ingredients] manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified,” Mylan’s statement said.
The FDA letter, however, said its regulators “remain concerned” with certain practices observed after the agency’s warning letter issued in the fall. Specifically, it called “inadequate” Mylan’s attempt to demonstrate that its cleaning program is robust enough to prevent contamination.
Mylan said it would send a formal reply to the FDA within the required 15 days.
Anya Litvak: alitvak@post-gazette.com or 412-263-1455.
First Published: September 2, 2020, 10:30 a.m.
Updated: September 2, 2020, 10:48 a.m.
