FDA Inspection
VGI Medical, LLCVGI Medical, LLC – FDA Inspection, Oct 8, 2009
Record Details
This FDA Inspection record concerns VGI Medical, LLC, with an inspection on October 8, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- VGI Medical, LLC
- Inspection Date
- October 8, 2009
- Product Type
- Biologics
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ID · 4939cbf5-ba8c-4441-bdfe-60811a674ba0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 618286
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VGI Medical, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 3, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 2, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for VGI Medical, LLC
- FDA Inspection 1199651 - 2023-02-06
- FDA Inspection 1046788 - 2018-03-21
- FDA Inspection 1028394 - 2017-05-31
- FDA Inspection 928679 - 2015-06-03
- FDA Inspection 825400 - 2013-04-02
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