FDA Inspection
Argon Medical Devices Inc.Argon Medical Devices Inc. – FDA Inspection, Jan 18, 2012
Record Details
This FDA Inspection record concerns Argon Medical Devices Inc., with an inspection on January 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Argon Medical Devices Inc.
- Inspection Date
- January 18, 2012
- Product Type
- Devices
View Company Profile
ID · c367f7ad-2e37-48fe-a803-9cd78ff98c60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769247
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Argon Medical Devices Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Argon Medical Devices Inc.
- FDA Inspection 971061 - 2016-05-04
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