FDA Inspection
Fuse Medical LLC.Fuse Medical LLC. – FDA Inspection, Sep 25, 2014
Record Details
This FDA Inspection record concerns Fuse Medical LLC., with an inspection on September 25, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Fuse Medical LLC.
- Inspection Date
- September 25, 2014
- Product Type
- Biologics
View Company Profile
ID · 6b518f76-f675-40b1-ba59-6a16a88de6bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898340
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Fuse Medical LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fuse Medical LLC.
- FDA Inspection 920976 - 2015-04-01
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