February 28, 2019 / 12:35 PM / 4 months ago

FDA flags sanitation concerns at Akorn's Amityville plant

Feb 28 (Reuters) - Akorn Inc said on Thursday the U.S. Food and Drug Administration issued observations related to inspection of the company’s manufacturing facility in Amityville, New York.

Records were not kept for maintenance, cleaning, sanitizing and inspection of equipment, the FDA said in a Form 483 dated Feb. 13.

Akorn was issued a warning letter last month from the FDA for its manufacturing plant in Decatur, Illinois highlighting violations. (Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta)

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