FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Equipment Malfunctions, Contamination Issues Nab 483 Citations for Akorn

Oct. 25, 2016
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Akorn Pharmaceuticals continued drug production when equipment malfunctions would normally require it to abort the batch, the FDA said in a Form 483.

The Illinois-based company was cited for several GMP issues, including potential contamination of drug products.

Additionally, production personnel failed to reject drugs that were manufactured in a clean room that were exposed due to a fear of not meeting fill yield requirements.

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