FDA Inspection
North American Medical Corp. (NAM)North American Medical Corp. (NAM) – FDA Inspection, Sep 7, 2011
Record Details
This FDA Inspection record concerns North American Medical Corp. (NAM), with an inspection on September 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 7, 2011
- Product Type
- Devices
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ID · 240f170d-c52c-4636-9347-f9ecfe5ab2bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745993
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of North American Medical Corp. (NAM)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for North American Medical Corp. (NAM)
- FDA Inspection 1192654 - 2022-12-09
- FDA Inspection 929721 - 2015-06-04
- FDA Inspection 571505 - 2009-02-03
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