FDA Inspection
Randox Laboratories, LimitedRandox Laboratories, Limited – FDA Inspection, Nov 29, 2012
Record Details
This FDA Inspection record concerns Randox Laboratories, Limited, with an inspection on November 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Randox Laboratories, Limited
- Inspection Date
- November 29, 2012
- Product Type
- Devices
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ID · ba313df0-02c5-48c9-a6f4-682bb787683b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817316
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Randox Laboratories, Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2017 | Not classified | Office of Inspections and Investigations | |
| April 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Randox Laboratories, Limited
- FDA Inspection 1015099 - 2017-06-01
- FDA Inspection 969545 - 2016-04-28
- FDA Inspection 969514 - 2016-04-28
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