Company
United KingdomAxis-Shield Diagnostics, Ltd., Dundee, United Kingdom – FDA Inspections
Inspection records and compliance data for Axis-Shield Diagnostics, Ltd. in Dundee. 2 FDA inspections on record, 1 Form 483, last inspected October 25, 2018.
Company Profile
This profile covers Axis-Shield Diagnostics, Ltd. based in Dundee, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 23, 2016. Last inspected October 25, 2018.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Equipment design and installation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1072250 |
| June 23, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 988580 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Axis-Shield Diagnostics, Ltd.
FEI Number
3002808140
Address
17 Luna Place, Dnd, Dundee, United Kingdom
Country
United Kingdom
ID: 72e5ea47-c610-44a5-8a0b-e70a4a4bc8a6