483
Surgery Pharmacy Services IncFDA 483 - Surgery Pharmacy Services Inc - December 06, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · 454c4048-aaeb-492e-821a-b59c2ce534fc