FDA Inspection
General Devices LlcGeneral Devices Llc – FDA Inspection, Jul 29, 2010
Record Details
This FDA Inspection record concerns General Devices Llc, with an inspection on July 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- General Devices Llc
- Inspection Date
- July 29, 2010
- Product Type
- Devices
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ID · dcf2dd96-0a03-42b5-ae17-1513dbcfd255
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678182
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 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 820.200(d)Service reports
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Other FDA inspections of General Devices Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 14, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for General Devices Llc
- FDA Inspection 1018328 - 2017-03-30
- FDA Inspection 931039 - 2015-06-11
- FDA Inspection 812713 - 2012-12-14
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