Akorn, Inc. — FDA 483 Findings

Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertainng to data retention and management.

An annual report did not include a full description of the manufactuing and control changes not r equiring a supplemental application, listed by date in the order in which they were implemented.

Your firm faile4 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 bas already been distributed.

Control procedure are not established which 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.

The inspection revealed numerous instances where your operators did not follow AA245 Cleaning & Sanitization of Manufacturing Areas, revision 40, designed to clean and disinfect the critical areas of the aseptic processing room.

Reserve samples from representative sample lots of batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

The written stability program for drug products does not include reliable meaningful, and specific test methods.

Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.

Each container or grouping of containers of component is not examined visually upon receipt and b efore acceptance for container damage, broken seals, or contamination.

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

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.

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and/or significant chemical, physical, or other change or deterioration in a distributed drug product.