Company
GermanySimex Medizintechnik Gmbh, Deislingen, Germany – FDA Inspections
Inspection records and compliance data for Simex Medizintechnik Gmbh in Deislingen. 3 FDA inspections on record, 3 Form 483s, last inspected September 04, 2024.
Company Profile
This profile covers Simex Medizintechnik Gmbh based in Deislingen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected November 15, 2017. Last inspected September 4, 2024.
Most cited issue areas
- Design history file1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2024 | Not classified | Medical Devices & Rad Health | 1249155 |
| October 10, 2018 | Not classified | Medical Devices & Rad Health | 1121259 |
| November 15, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1031382 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Simex Medizintechnik Gmbh
FEI Number
3005813597
Address
Bruckstr. 30/1, Deislingen, Germany
Country
Germany
ID: e6a56605-72a2-44cd-91ea-2d65fa683e05