FDA Inspection
North American Medical Corp. (NAM)North American Medical Corp. (NAM) – FDA Inspection, Jun 4, 2015
Record Details
This FDA Inspection record concerns North American Medical Corp. (NAM), with an inspection on June 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 4, 2015
- Product Type
- Devices
View Company Profile
ID · 1742cd17-2632-47ba-9d7f-fa7500510665
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929721
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 13 citations.
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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 |
| September 7, 2011 | 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 745993 - 2011-09-07
- FDA Inspection 571505 - 2009-02-03
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