FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Equipment Malfunctions, Contamination Issues Nab 483 Citations for Akorn

Oct. 25, 2016

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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