FDA Inspection
DEROYAL INDUSTRIES, INC.DEROYAL INDUSTRIES, INC. – FDA Inspection, Aug 19, 2010
Record Details
This FDA Inspection record concerns DEROYAL INDUSTRIES, INC., with an inspection on August 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DEROYAL INDUSTRIES, INC.
- Inspection Date
- August 19, 2010
- Product Type
- Devices
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ID · bc1b4e06-fd71-4355-bd84-a8b2dff90222
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676551
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of DEROYAL INDUSTRIES, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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