Drugs

13 Observations in Akorn Inspection FDA-483

FDA has released the FDA-483 issued following a 4/9-5/18 inspection at Akorn, a sterile drug manufacturer in Decatur, IL. Specific observations in the document were:

failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
failing to include in an annual report a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented;
failing to establish an adequate system for cleaning and disinfecting the room and equipment used to produce aseptic conditions;
failing to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management;
failing to submit an NDA-Field Alert Report within three working days of receiving information concerning bacteriological contamination and/or significant chemical, physical, or other change or deterioration in a distributed drug product;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance;
failing to examine visually upon receipt and before acceptance of each container or grouping of containers of components for container damage, broken seals, or contamination;
failing to have the written stability program for drug products include reliable, meaningful, and specific test methods;
failing to establish control procedures that monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions; and
failing to examine visually for evidence of deterioration at least once a year reserve samples from representative sample lots or batches of drug product selected by acceptable statistical procedures.

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