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Pharmaceuticals / Inspections and Audits

FDA Re-Inspection Clears Akorn’s Facility in Illinois for Production

Dec. 20, 2016
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FDA investigators have cleared Akorn’s facility in Illinois for production, following a re-inspection that confirmed the company corrected several GMP deficiencies.

The agency handed Akorn a Form 483 in October, after a June inspection of the company’s Decatur facility revealed more than a half-a-dozen citations, including shortcomings in the sterile manufacturing procedures that should have halted the production of drug batches.

Facility managers acknowledged these major inadequacies, but the company proceeded to allow production.

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