FDA Inspection
DeRoyal Industries IncDeRoyal Industries Inc – FDA Inspection, Aug 26, 2010
Record Details
This FDA Inspection record concerns DeRoyal Industries Inc, with an inspection on August 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DeRoyal Industries Inc
- Inspection Date
- August 26, 2010
- Product Type
- Devices
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ID · dd2a5097-c0bf-4fb4-abbb-377a5c3343f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678543
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of DeRoyal Industries Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DeRoyal Industries Inc
- FDA Inspection 1019823 - 2017-07-25
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