FDA Inspection
Arteriocyte Medical Systems IncArteriocyte Medical Systems Inc – FDA Inspection, Dec 11, 2012
Record Details
This FDA Inspection record concerns Arteriocyte Medical Systems Inc, with an inspection on December 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 11, 2012
- Product Type
- Devices
View Company Profile
ID · 59e61166-332b-4189-86c4-b2737943992b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810191
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Arteriocyte Medical Systems Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 24, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 1, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arteriocyte Medical Systems Inc
- FDA Inspection 1113436 - 2019-11-15
- FDA Inspection 1057303 - 2018-05-24
- FDA Inspection 946533 - 2015-10-01
- FDA Inspection 640530 - 2010-01-25
- FDA Inspection 597067 - 2009-07-10
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