FDA Inspection
NovaBone Products LLCNovaBone Products LLC – FDA Inspection, Mar 20, 2015
Record Details
This FDA Inspection record concerns NovaBone Products LLC, with an inspection on March 20, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NovaBone Products LLC
- Inspection Date
- March 20, 2015
- Product Type
- Devices
View Company Profile
ID · f32d06fe-76e8-4c6c-990f-5b555371dd2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919526
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of NovaBone Products LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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