FDA Inspection
Elite Orthopedics, LLCElite Orthopedics, LLC – FDA Inspection, Jul 15, 2025
Record Details
This FDA Inspection record concerns Elite Orthopedics, LLC, with an inspection on July 15, 2025, issued by the Kansas City District Office, covering biologics.
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ID · c35d70ad-e9ea-4717-aef7-054b603c1201
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1275657
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.180(c)Availability of procedures
- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.270(b)Management system re: core CGTPs
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Other FDA inspections of Elite Orthopedics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 28, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Elite Orthopedics, LLC
- FDA Inspection 1066849 - 2018-08-28
- FDA Inspection 948009 - 2015-10-28
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