FDA Inspection
Simex Medizintechnik GmbhSimex Medizintechnik Gmbh – FDA Inspection, Sep 4, 2024
Record Details
This FDA Inspection record concerns Simex Medizintechnik Gmbh, with an inspection on September 4, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Simex Medizintechnik Gmbh
- Inspection Date
- September 4, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 70425ae6-2340-4924-98be-5daf99c102c0
Inspection Facts
- Inspection number
- 1249155
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Simex Medizintechnik Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2018 | Not classified | Office of Inspections and Investigations | |
| November 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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