FDA Inspection
Sivantos GmbHSivantos GmbH – FDA Inspection, Oct 31, 2013
Record Details
This FDA Inspection record concerns Sivantos GmbH, with an inspection on October 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sivantos GmbH
- Inspection Date
- October 31, 2013
- Product Type
- Devices
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ID · 9982a2df-d782-4969-8e2e-b4e68cfda7d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857143
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 806.20(a)Records not kept
- 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 |
|---|---|---|---|
| February 2, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Sivantos GmbH
- FDA Inspection 1196667 - 2023-02-02
- FDA Inspection 1079959 - 2018-05-17
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