FDA Inspection
Supreme Orthopedic Systems - NOVASupreme Orthopedic Systems - NOVA – FDA Inspection, Apr 10, 2024
Record Details
This FDA Inspection record concerns Supreme Orthopedic Systems - NOVA, with an inspection on April 10, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c1f6ca7d-f0eb-4f15-9ae6-f147d3eff288
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235551
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.290(d)Recording I.D. code and type of HCT/P
- 21 CFR 1271.160(d)Documentation/approval prior to implementation
- 21 CFR 1271.260(e)Periodic review of temperatures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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