Company
GermanyMondeal Medical Systems Gmbh, Muhlheim An Der Donau, Germany – FDA Inspections
Inspection records and compliance data for Mondeal Medical Systems Gmbh in Muhlheim An Der Donau. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 19, 2019.
Company Profile
This profile covers Mondeal Medical Systems Gmbh based in Muhlheim An Der Donau, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 24, 2014. Last inspected September 19, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1102228 |
| January 24, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 865973 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mondeal Medical Systems Gmbh
FEI Number
3004517085
Address
Am Gewerbering 7, Muhlheim An Der Donau, Germany
Country
Germany
ID: 3c5d3cef-3c71-40b2-b28a-508d863fd90a