FDA Inspection
DeRoyal Industries, Inc.DeRoyal Industries, Inc. – FDA Inspection, May 22, 2014
Record Details
This FDA Inspection record concerns DeRoyal Industries, Inc., with an inspection on May 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DeRoyal Industries, Inc.
- Inspection Date
- May 22, 2014
- Product Type
- Devices
View Company Profile
ID · fc515e22-56de-48ac-8ee2-0e8abadf9f5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 880853
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 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
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- 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
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Other FDA inspections of DeRoyal Industries, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2012 | 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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