FDA Inspection
Harris Medical ResourcesHarris Medical Resources – FDA Inspection, Oct 9, 2009
Record Details
This FDA Inspection record concerns Harris Medical Resources, with an inspection on October 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Harris Medical Resources
- Inspection Date
- October 9, 2009
- Product Type
- Devices
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ID · 8dbaa1cc-5ea5-408e-bbb8-761e4acb3978
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620326
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.2(c)(7)Needs IDE; does not meet definition of a custom device
- 21 CFR 812.7(b)Commercialization
- 21 CFR 812.18(b)Exporter of investigational device
- 21 CFR 812.40Sponsors" general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Harris Medical Resources
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Harris Medical Resources
- FDA Inspection 731318 - 2011-05-18
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