FDA Inspection
Gunnell LlcGunnell Llc – FDA Inspection, Aug 24, 2012
Record Details
This FDA Inspection record concerns Gunnell Llc, with an inspection on August 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gunnell Llc
- Inspection Date
- August 24, 2012
- Product Type
- Devices
View Company Profile
ID · 59c9a640-0058-4f46-a730-adff193d37f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793234
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gunnell Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 23, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 30, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gunnell Llc
- FDA Inspection 959099 - 2016-02-18
- FDA Inspection 732620 - 2011-06-23
- FDA Inspection 670779 - 2010-06-30
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