FDA Inspection
Elite Spine LLCElite Spine LLC – FDA Inspection, Nov 16, 2016
Record Details
This FDA Inspection record concerns Elite Spine LLC, with an inspection on November 16, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f466e248-b550-44c9-90ea-30f504ba471e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 992243
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
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Other FDA inspections of Elite Spine LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 15, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Elite Spine LLC
- FDA Inspection 1220146 - 2023-08-21
- FDA Inspection 1018942 - 2017-06-15
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