FDA Inspection
Novamed USA, Inc.Novamed USA, Inc. – FDA Inspection, May 7, 2009
Record Details
This FDA Inspection record concerns Novamed USA, Inc., with an inspection on May 7, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Novamed USA, Inc.
- Inspection Date
- May 7, 2009
- Product Type
- Devices
View Company Profile
ID · 6eebe95a-e11d-4284-b120-cfab07b505a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 585988
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184DHR content
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Other FDA inspections of Novamed USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Novamed USA, Inc.
- FDA Inspection 998087 - 2017-01-25
- FDA Inspection 797903 - 2012-09-06
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