FDA Inspection
Supreme Orthopedic Systems IncSupreme Orthopedic Systems Inc – FDA Inspection, Aug 23, 2024
Record Details
This FDA Inspection record concerns Supreme Orthopedic Systems Inc, with an inspection on August 23, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 47759d00-470c-4d2c-8c49-3b64039eb963
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1247814
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.200(a)Capable of valid results
- 21 CFR 1271.260(e)Periodic review of temperatures
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Supreme Orthopedic Systems Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 16, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Supreme Orthopedic Systems Inc
- FDA Inspection 1087637 - 2019-04-05
- FDA Inspection 970798 - 2016-05-16
- FDA Inspection 811144 - 2012-12-14
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