FDA 483 - Surgery Pharmacy Services Inc - July 07, 2023

An FDA inspection of Surgery Pharmacy Services Inc in Chattanooga, TN, a producer of sterile drug products, revealed significant deficiencies in aseptic processing controls. Observations included inadequately performed smoke studies, media fills that did not simulate actual production, and facility design issues allowing unclassified air into ISO 7 classified sterile compounding areas. These issues raise concerns about the sterility assurance of compounded products.