# Sivantos GmbH – FDA Inspection, Feb 2, 2023

Source: https://www.keypedia.com/records/fda_inspections/sivantos-gmbh/ef78ec40-bada-45d0-816d-a9cff79e7289
Source feed: FDA_Inspections

> FDA inspection 1196667 of Sivantos GmbH, February 02, 2023. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR part 803. Form 483 issued. 2 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1196667
- Company Name: Sivantos GmbH
- Inspection Date: 2023-02-02
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 2

## Related Documents

- FDA Inspection 1079959 - 2018-05-17
- [FDA Inspection 857143 - 2013-10-31](https://www.keypedia.com/records/fda_inspections/sivantos-gmbh/9982a2df-d782-4969-8e2e-b4e68cfda7d9)

## Related Officers

- [Investigator](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/sivantos-gmbh/bbdf956b-4050-44c2-99f4-f5c12836cda7

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7