FDA Inspection
Hurricane Medical, Inc.Hurricane Medical, Inc. – FDA Inspection, Jul 5, 2011
Record Details
This FDA Inspection record concerns Hurricane Medical, Inc., with an inspection on July 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hurricane Medical, Inc.
- Inspection Date
- July 5, 2011
- Product Type
- Devices
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ID · bea5bb4c-bb1c-42cc-b0c6-5b67f9afda66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 733222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Hurricane Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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