FDA Inspection
BZ Medical, Inc.BZ Medical, Inc. – FDA Inspection, Aug 15, 2017
Record Details
This FDA Inspection record concerns BZ Medical, Inc., with an inspection on August 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 886e39a4-9518-4522-a95f-cb3aae1a0a7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021665
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of BZ Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BZ Medical, Inc.
- FDA Inspection 859918 - 2013-12-27
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