FDA 483 - Surgery Pharmacy Services Inc - December 06, 2019

An FDA inspection of Surgery Pharmacy Services, Inc. in Chattanooga, TN, a producer of sterile drugs, revealed significant deficiencies in aseptic processing and quality control. Observations included microbial contamination, inadequate personnel practices, unsterile disinfecting agents, and release of drug products failing assay testing. These issues indicate a high risk to product sterility and patient safety.