483
Surgery Pharmacy Services IncSurgery Pharmacy Services Inc – FDA 483, Dec 6, 2019
Record Details
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.
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ID · 454c4048-aaeb-492e-821a-b59c2ce534fc
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