Company
GermanyQualiMed Innovative Medizinprodukte GmbH, Winsen (Luhe), Germany – FDA Inspections
Inspection records and compliance data for QualiMed Innovative Medizinprodukte GmbH in Winsen (Luhe). 1 FDA inspection on record, 1 Form 483, last inspected April 06, 2023.
Company Profile
This profile covers QualiMed Innovative Medizinprodukte GmbH based in Winsen (Luhe), Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 6, 2023.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2023 | VAI | Medical Devices & Rad Health | 1203799 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
QualiMed Innovative Medizinprodukte GmbH
FEI Number
3004193137
Address
Boschstr. 16, Winsen (Luhe), Germany
Country
Germany
ID: 44032d4e-0e62-427d-a4bb-cdc7595fec5c