FDA Inspection
Randox Laboratories, LimitedRandox Laboratories, Limited – FDA Inspection, Apr 28, 2016
Record Details
This FDA Inspection record concerns Randox Laboratories, Limited, with an inspection on April 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Randox Laboratories, Limited
- Inspection Date
- April 28, 2016
- Product Type
- Devices
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ID · b853afcb-4867-4185-a251-15dda3910551
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969514
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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 |
| November 29, 2012 | 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 817316 - 2012-11-29
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