FDA Inspection
Amedica Biotech, Inc.Amedica Biotech, Inc. – FDA Inspection, Mar 24, 2011
Record Details
This FDA Inspection record concerns Amedica Biotech, Inc., with an inspection on March 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amedica Biotech, Inc.
- Inspection Date
- March 24, 2011
- Product Type
- Devices
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ID · 2d0db854-6c07-4aba-8a78-710a243d3dbe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711879
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Amedica Biotech, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amedica Biotech, Inc.
- FDA Inspection 814172 - 2013-01-18
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