FDA Inspection
JosNoe Medical, Inc.JosNoe Medical, Inc. – FDA Inspection, Nov 29, 2011
Record Details
This FDA Inspection record concerns JosNoe Medical, Inc., with an inspection on November 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- JosNoe Medical, Inc.
- Inspection Date
- November 29, 2011
- Product Type
- Devices
View Company Profile
ID · 1f312f6a-4595-4280-904f-b67e53f5f4cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754793
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of JosNoe Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for JosNoe Medical, Inc.
- FDA Inspection 872673 - 2014-04-04
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