Company
GermanyDornier Medtech Systems GmbH, Wesling, Germany – FDA Inspections
Inspection records and compliance data for Dornier Medtech Systems GmbH in Wesling. 2 FDA inspections on record (1 OAI), last inspected December 14, 2022.
Company Profile
This profile covers Dornier Medtech Systems GmbH based in Wesling, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 29, 2011. Last inspected December 14, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1194137 |
| April 29, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 726892 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dornier Medtech Systems GmbH
FEI Number
3002806833
Address
Argelsrieder Feld 7, Wesling, Germany
Country
Germany
ID: c0c5cabc-b89f-4ca5-9146-659dbfd4f750