FDA 483 - Federal Package Network, Inc - December 13, 2024

An FDA inspection of Federal Package Network, Inc. in Chanhassen, MN, a drug manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate laboratory controls, including unvalidated HPLC methods and poor data integrity practices, as well as failures in thoroughly investigating discrepancies and out-of-specification results. Additionally, the inspection found issues with process validation for OTC drug products and a lack of adherence to quality unit responsibilities.