FDA Inspection
VGI Medical, LLCVGI Medical, LLC – FDA Inspection, Mar 21, 2018
Record Details
This FDA Inspection record concerns VGI Medical, LLC, with an inspection on March 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 984f9778-7ed4-4990-a9e0-85df46a82211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046788
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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 |
| 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 |
| September 21, 2010 | 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 1028394 - 2017-05-31
- FDA Inspection 928679 - 2015-06-03
- FDA Inspection 825400 - 2013-04-02
- FDA Inspection 681253 - 2010-09-21
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