FDA Inspection
Supreme Orthopedic Systems IncSupreme Orthopedic Systems Inc – FDA Inspection, Dec 14, 2012
Record Details
This FDA Inspection record concerns Supreme Orthopedic Systems Inc, with an inspection on December 14, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 14, 2012
- Product Type
- Biologics
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ID · c18ea055-d2f9-4e97-a6a9-a314d4052f1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811144
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.160(d)Documentation/approval prior to implementation
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Other FDA inspections of Supreme Orthopedic Systems Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
Other documents for Supreme Orthopedic Systems Inc
- FDA Inspection 1247814 - 2024-08-23
- FDA Inspection 1087637 - 2019-04-05
- FDA Inspection 970798 - 2016-05-16
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