FDA Inspection
Gunnell LlcGunnell Llc – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns Gunnell Llc, with an inspection on June 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gunnell Llc
- Inspection Date
- June 23, 2011
- Product Type
- Devices
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ID · 723cab16-52da-4e6b-bef1-a1baaae16791
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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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 |
| August 24, 2012 | 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 793234 - 2012-08-24
- FDA Inspection 670779 - 2010-06-30
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