FDA Targets Generics Manufacturer Mylan for Continuous Quality Problems, an Industrial Info Market Brief

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Generics manufacturer Mylan once enjoyed an ongoing clean safety record with the U.S. Food and Drug Administration (FDA). Today, the company is finding itself repeatedly in the agency's spotlight due to problems with quality.

With a vast global network of manufacturing plants, the company produces active pharmaceutical ingredients (APIs) for a wide range of generic drug products, along with final formulations. A recent warning by the FDA over contamination problems found within Mylan's Indian Unit 7 in Medak, India, follows a similar one issued last year for the company's Unit 8 in Vizianagaram, India.

In 2018, the company was notified about problems at its Morgantown, West Virginia, manufacturing plant. Inspectors noted cleaning processes that did not offer adequate protection from contamination risks, as well as thorough investigations into why some of the site's drug products did not meet certain testing requirements.

The FDA's most recent warning letter stated: "These repeated failures at multiple sites manufacturing API demonstrate that your company's oversight and control over the manufacture of drugs is inadequate. You should immediately and comprehensively assess your company's global manufacturing operations."

See below for a map showing Mylan's global manufacturing sites.