FDA Inspection
Advanced Fusion LLCAdvanced Fusion LLC – FDA Inspection, Dec 7, 2018
Record Details
This FDA Inspection record concerns Advanced Fusion LLC, with an inspection on December 7, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ff309c22-543b-4530-9b6a-895a1c179566
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073753
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.265(e)Documentation elements for activities
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Other FDA inspections of Advanced Fusion LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 6, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Advanced Fusion LLC
- FDA Inspection 865007 - 2014-02-03
- FDA Inspection 771158 - 2012-03-06
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