In a rebuke to Mylan (MYL), the Food and Drug Administration warned the big generic drug maker about a host of manufacturing gaffes at a key plant in the U.S. that has been the focus of large job cuts this year.
Following an inspection last March and April of the Morgantown, W.Va., facility, the FDA noted that Mylan failed to clean equipment, investigate unexplained discrepancies in batches of drugs, and follow proper procedures to assure medicines have the intended quality and purity.
Moreover, the agency reminded the company of repeated violations at multiple sites that were found over the past three years. In 2015, three facilities in India were issued a combined warning letter for inadequate controls for making sterile drugs and failing to establish scientifically sound lab controls, among other things. Last year, a plant in India was given a warning letter for invalidating test results.
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