Company
IrelandRANDOX TEORANTA, Dungloe, Ireland – FDA Inspections
Inspection records and compliance data for RANDOX TEORANTA in Dungloe. 2 FDA inspections on record, 1 Form 483, last inspected June 07, 2018.
Company Profile
This profile covers RANDOX TEORANTA based in Dungloe, Ireland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 5, 2013. Last inspected June 7, 2018.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Failure to submit1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1054635 |
| December 5, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 861149 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
RANDOX TEORANTA
FEI Number
3009473156
Address
Meenmore, Dungloe, Ireland
Country
Ireland
ID: c5af8a7f-a75e-410a-88fc-fa5600771cdf