FDA Inspection
GraftSource, LLCGraftSource, LLC – FDA Inspection, Jan 11, 2012
Record Details
This FDA Inspection record concerns GraftSource, LLC, with an inspection on January 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- GraftSource, LLC
- Inspection Date
- January 11, 2012
- Product Type
- Biologics
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ID · 62b500bc-9412-4898-81b1-7d5090a4bcd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 762433
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of GraftSource, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 19, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 5, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 6, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for GraftSource, LLC
- FDA Inspection 1279228 - 2025-08-20
- FDA Inspection 1105852 - 2019-09-19
- FDA Inspection 1035434 - 2017-12-05
- FDA Inspection 865744 - 2014-02-06
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