FDA Inspection
Newport Medical Instruments IncNewport Medical Instruments Inc – FDA Inspection, Apr 13, 2011
Record Details
This FDA Inspection record concerns Newport Medical Instruments Inc, with an inspection on April 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 13, 2011
- Product Type
- Devices
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ID · 5a06becc-c20d-43ff-b492-cc793b3ba993
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722370
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Newport Medical Instruments Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 29, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Newport Medical Instruments Inc
- FDA Inspection 1020126 - 2017-07-10
- FDA Inspection 561409 - 2009-01-29
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