Equipment Malfunctions, Contamination Issues Nab 483 Citations for Akorn

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.