FDA Inspection
Simex Medizintechnik GmbhSimex Medizintechnik Gmbh – FDA Inspection, Nov 15, 2017
Record Details
This FDA Inspection record concerns Simex Medizintechnik Gmbh, with an inspection on November 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b4477be9-9d78-40c9-89d2-8725d79ef6d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031382
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Simex Medizintechnik Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2024 | Not classified | Office of Inspections and Investigations | |
| October 10, 2018 | Not classified | Office of Inspections and Investigations |
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