Company
GermanyRAUMEDIC - MUENCHBERG, Helmbrechts, Germany – FDA Inspections
Inspection records and compliance data for RAUMEDIC - MUENCHBERG in Helmbrechts. 3 FDA inspections on record, 2 Form 483s, last inspected February 02, 2023.
Company Profile
This profile covers RAUMEDIC - MUENCHBERG based in Helmbrechts, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 29, 2015. Last inspected February 2, 2023.
Most cited issue areas
- Design validation - documentation1 inspection
- Design validation - Risk analysis1 inspection
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1196563 |
| November 2, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1031821 |
| January 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 917689 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
RAUMEDIC - MUENCHBERG
FEI Number
3006946348
Address
Hermann-Staudinger-Str. 2, Helmbrechts, Germany
Country
Germany
ID: 88b436ec-f171-44b6-97b6-4c393ea5aad5