FDA 483 - Eagle Pharma Outsourcing LLC - August 12, 2021

Eagle Pharmacy, Inc., an outsourcing facility in Hoover, AL, was inspected by the FDA and cited for significant deficiencies in its aseptic processing, laboratory controls, and quality systems. Observations included inadequate environmental monitoring, poor cleaning practices, insufficient validation of aseptic processes, incomplete batch records, and a failure to investigate deviations from stability protocols. These issues indicate a high potential for product contamination and lack of control over sterile drug manufacturing.