FDA 483 - Akom Pharmaceuticals, Inc.

Akorn Pharmaceuticals, Inc. in Decatur, IL, was inspected and received a Form 483 with six observations related to significant deficiencies in their sterile drug product manufacturing processes. The observations highlight critical issues across production, quality control, and laboratory systems, including failures in recording deviations, inadequate batch record reconciliation, insufficient investigation of batch failures, and scientifically unsound sampling and environmental monitoring practices. These findings indicate a lack of robust controls necessary to ensure the quality and sterility of their drug products.