FDA Inspection
Sivantos GmbHSivantos GmbH – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns Sivantos GmbH, with an inspection on February 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef78ec40-bada-45d0-816d-a9cff79e7289
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sivantos GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2018 | Not classified | Office of Inspections and Investigations | |
| October 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sivantos GmbH
- FDA Inspection 1079959 - 2018-05-17
- FDA Inspection 857143 - 2013-10-31
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