FDA Inspection
GraftSource, LLC.GraftSource, LLC. – FDA Inspection, Jun 12, 2014
Record Details
This FDA Inspection record concerns GraftSource, LLC., with an inspection on June 12, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- GraftSource, LLC.
- Inspection Date
- June 12, 2014
- Product Type
- Biologics
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ID · 4e760eeb-6ae8-46f7-a99a-d917fb67446e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 882810
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.260(e)Periodic review of temperatures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GraftSource, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 19, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for GraftSource, LLC.
- FDA Inspection 1277702 - 2025-07-17
- FDA Inspection 1014007 - 2017-01-19
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