FDA flags concerns at Akorn's Amityville plant, shares slip [Reuters]
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Source: Reuters
FDA flags concerns at Akorn's Amityville plant, shares slip | Reuters 3 Min Read (Reuters) - Generic drugmaker Akorn Inc said on Thursday the U.S. Food and Drug Administration had raised concerns about its manufacturing plant in Amityville, New York, that included a lack of records on the maintenance and cleaning of equipment. The FDA’s issuance of the notice following an inspection of the plant, through a so-called Form 483, is the latest in a series of setbacks for Akorn and comes a month after the agency issued a warning letter related to another plant. The agency, following an inspection of the plant, also observed deficiencies in the facility’s systems for keeping its equipment free from contamination, the FDA said in the form dated Feb. 13. The FDA said it found that containers in the plant were not tested for conformance with written procedures, and highlighted the more than 50 customer complaints, over the last year, related to malfunctions in the spray or dropper of Akorn’s p
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