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Stock impact report

UPDATE 1-FDA flags concerns at Akorn's Amityville plant [Reuters]

AKORN (AKRX) 
Last akorn earnings: 10/31 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.akorn.com
Company Research Source: Reuters
FDA flags concerns at Akorn's Amityville plant (Reuters) - Akorn Inc said on Thursday the U.S. Food and Drug Administration pointed out certain concerns at its manufacturing plant in Amityville, New York, that included lack of records on the maintenance and cleaning of equipment. 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 a Form 483 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 products. Akorn was issued a warning letter last month from the FDA for another manufacturing plant in Decatur, Illinois highlighting violations such as failure to follow procedures to prevent contamination of drugs produced at the plant. Last April, Germany’s Fresenius SE & Co KG Show less Read more
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