FDA Inspection
Norman Noble IncNorman Noble Inc – FDA Inspection, Dec 19, 2024
Record Details
This FDA Inspection record concerns Norman Noble Inc, with an inspection on December 19, 2024, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 231e8d43-8794-406f-99ba-c1b0f122f1e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1257092
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Norman Noble Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | VAI | Center for Devices and Radiological Health | Compliance: 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 1201899 - 2023-03-24
- 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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