FDA Inspection
Frye Electronics IncFrye Electronics Inc – FDA Inspection, Apr 20, 2017
Record Details
This FDA Inspection record concerns Frye Electronics Inc, with an inspection on April 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Gorveatt (Issuing Officer)
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ID · 74b7a1ca-5aae-4337-8420-b63fcbbe79a3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1009930
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
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Other FDA inspections of Frye Electronics Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Frye Electronics Inc
- FDA Inspection 881444 - 2014-06-03
- FDA Inspection 789705 - 2012-07-03
- FDA Inspection 597086 - 2009-07-21
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