Company
DenmarkUnomedical A/S, Lejre, Denmark – FDA Inspections
Inspection records and compliance data for Unomedical A/S in Lejre. 3 FDA inspections on record, 1 Form 483, last inspected May 24, 2024.
Company Profile
This profile covers Unomedical A/S based in Lejre, Denmark.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 30, 2014. Last inspected May 24, 2024.
Most cited issue areas
- Design validation - production units1 inspection
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1241138 |
| February 28, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1043245 |
| October 30, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 903722 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Unomedical A/S
FEI Number
1000477110
Address
Osted, Aholmvej 1 - 3, Lejre, Denmark
Country
Denmark
ID: 43411101-e4e5-4366-95e0-ee8269559cd5