FDA Inspection
DeRoyal Industries, Inc.DeRoyal Industries, Inc. – FDA Inspection, Sep 26, 2012
Record Details
This FDA Inspection record concerns DeRoyal Industries, Inc., with an inspection on September 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DeRoyal Industries, Inc.
- Inspection Date
- September 26, 2012
- Product Type
- Devices
View Company Profile
ID · 66f699f8-0bd5-4f11-8c15-59b49c53c0b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800786
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of DeRoyal Industries, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 31, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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