FDA Inspection
Avantis MedicalAvantis Medical – FDA Inspection, Jul 24, 2009
Record Details
This FDA Inspection record concerns Avantis Medical, with an inspection on July 24, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avantis Medical
- Inspection Date
- July 24, 2009
- Product Type
- Devices
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ID · 517ae3a9-3ef4-4bd4-9a87-7b2f5fed435b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620295
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(f)Design verification acceptance criteria
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Avantis Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 8, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avantis Medical
- FDA Inspection 983344 - 2016-03-10
- FDA Inspection 785019 - 2012-06-08
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