Company
SwedenHemoCue AB, Angelholm, Sweden – FDA Inspections
Inspection records and compliance data for HemoCue AB in Angelholm. 3 FDA inspections on record, 1 Form 483, last inspected May 31, 2018.
Company Profile
This profile covers HemoCue AB based in Angelholm, Sweden.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected October 26, 2011. Last inspected May 31, 2018.
Most cited issue areas
- Supplier oversight1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 31, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1055264 |
| March 20, 2013 | NAI | Biologics · Blood and Blood Products | 825448 |
| October 26, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 750673 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HemoCue AB
FEI Number
3003044483
Address
Kuvettgatan 1, Angelholm, Sweden
Country
Sweden
ID: 3e9b45a6-a7c5-4508-aabb-7529e5bb8c0b