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Pharmaceuticals / Inspections and Audits

FDA Warns Akorn Over Conditions at Sterile Drug Facility

Jan. 16, 2019

The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois over poor aseptic conditions observed during an inspection last spring.

The agency issued a Form 483 following the April 9-May 16, 2018 inspection, but it was not satisfied with Akorn’s written responses, noting that the company did not commit to extensively redesigning its aseptic process operations.

“We acknowledge you engaged a third party to assist in efforts to re-train personnel and provide additional oversight of aseptic practices,” the agency said. “However, you did not provide a sufficient evaluation of all batches produced under inadequate conditions.”

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