FDA Inspection
Elite Orthopedics, LLCElite Orthopedics, LLC – FDA Inspection, Dec 4, 2015
Record Details
This FDA Inspection record concerns Elite Orthopedics, LLC, with an inspection on December 4, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Elite Orthopedics, LLC
- Inspection Date
- December 4, 2015
- Product Type
- Biologics
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ID · ba75abe0-9928-4411-bfad-c50e7b476f70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951965
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Elite Orthopedics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Elite Orthopedics, LLC
- FDA Inspection 1115847 - 2020-01-15
- FDA Inspection 1049449 - 2018-04-05
- FDA Inspection 812513 - 2012-12-10
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