Mylan NV shares dropped 1.9% in midday trade Tuesday after the Food and Drug Administration released a warning letter to the company about violations at a manufacturing facility in India. Until all the violations are fixed, the regulator said it "may withhold approval" of new products manufactured by Mylan. The violations stemmed from a September FDA inspection of the factory. Though Mylan had responded to the FDA's concerns, the FDA said the responses were "inadequate." Mylan has not thoroughly investigated discrepancies in a batch of lab results, and hasn't set up a good quality control unit that can review production records, the FDA said. Mylan told MarketWatch that it is working closely with the FDA to address the issues in the letter. Spokeswoman Nina Devlin noted that the India facility is in good standing with other global regulatory entities, that production continues uninterrupted and that Mylan doesn't expect it to cause any supply issues. The facility is one of 50 worldwide, Devlin said, though she would not disclose what products are manufactured there. Wells Fargo analyst David Maris continued to rate the company market perform, saying "we do not know what products, if any, are manufactured at this plant, and as such, this may have little or no immediate commercial risk." But, "nothing is more critical for a brand or generic drug company than being able to ensure that its products are safe and effective," he said. Mylan shares have risen 3.3% over the last three months, compared with a 3.3% rise in the S&P 500 .
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