FDA Inspection
DeRoyal Industries IncDeRoyal Industries Inc – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns DeRoyal Industries Inc, with an inspection on March 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DeRoyal Industries Inc
- Inspection Date
- March 27, 2015
- Product Type
- Devices
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ID · f42bb0e4-1f37-4223-ab45-1a421193bf82
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920233
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of DeRoyal Industries Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DeRoyal Industries Inc
- FDA Inspection 1036396 - 2017-12-08
- FDA Inspection 889470 - 2014-08-11
- FDA Inspection 840139 - 2013-07-12
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