UPDATE 3-Akorn gets FDA warning letter for Illinois plant, shares drop [Reuters]
AKORN (AKRX)
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Source: Reuters
Akorn gets FDA warning letter for Illinois plant, shares drop (Reuters) - Akorn Inc said on Wednesday it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company’s Decatur, Illinois manufacturing plant last year. Shares of the company fell 8.9 percent to $3.59 in afternoon trading. The warning letter, dated Friday, lists violations related to the agency’s current good manufacturing practice regulations, which include poor aseptic behavior, as well as those related to environmental and personnel monitoring. The Lake Forest, Illinois-based company also failed to follow “appropriate written procedures” to prevent microbiological contamination of the drugs being produced at the plant, the letter said. The FDA said the company’s response to its Form 483, which lists observations from the inspection in April and May, was inadequate. RBC Capital analyst Randall Stanicky said the letter was not surprising given the company’s known quality is
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