FDA Inspection
Norman Noble IncNorman Noble Inc – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Norman Noble Inc, with an inspection on March 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb4ed907-0311-4281-9ab8-ea9dac1893a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201899
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Norman Noble Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | VAI | Cincinnati District Office | Compliance: Medical Devices |
| February 23, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Norman Noble Inc
- FDA Inspection 1257092 - 2024-12-19
- FDA Inspection 959744 - 2016-02-23
- FDA Inspection 898312 - 2014-09-30
- FDA Inspection 812401 - 2012-12-13
- FDA Inspection 749766 - 2011-10-12
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