Company
United KingdomRandox Laboratories, Limited, Crumlin, United Kingdom – FDA Inspections
Inspection records and compliance data for Randox Laboratories, Limited in Crumlin. 4 FDA inspections on record, last inspected June 01, 2017.
Company Profile
This profile covers Randox Laboratories, Limited based in Crumlin, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 29, 2012. Last inspected June 1, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Design history file1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2017 | Not classified | Medical Devices & Rad Health | 1015099 |
| April 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 969545 |
| April 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 969514 |
| November 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 817316 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Randox Laboratories, Limited
FEI Number
3004493545
Address
36/44 Largy Road, Crumlin, United Kingdom
Country
United Kingdom
ID: 8a08dce9-5103-4fad-a76a-546f1df5aa53