Akorn Hit With FDA Warning For Decatur Site In US

Akorn has again been pulled up by the FDA for deficiencies at its US manufacturing plant in Decatur, Illinois, concerning aseptic practices and cleaning procedures. Last year, the firm was issued a Form 483 inspection report for the site; now, it has been struck with an FDA warning letter.

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Akorn gets warning letter after audit at Decatur site • Source: Shutterstock

Akorn has suffered another blow at its US sterile manufacturing plant in Decatur, Illinois, receiving a warning letter from the US Food and Drug Administration (FDA) for the facility, after it was last year hit with a ‘Form 483’ inspection report.

Following an audit at the Decatur plant from 9 April to 16 May 2018, the agency issued a warning letter...

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