# FDA 483 - Siegfried Evionnaz SA - March 31, 2023

Source: https://www.keypedia.com/records/483/siegfried-evionnaz-sa/43a94a56-ca4a-4b09-affc-46158ba90c8d

> FDA 483 for Siegfried Evionnaz SA on March 31, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Siegfried Evionnaz SA
- Inspection Date: 2023-03-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Siegfried Evionnaz SA, an API manufacturer in Evionnaz, Switzerland, revealed significant deficiencies across three observations. These included inadequately designed and maintained production equipment, failure to monitor API stability characteristics as per procedures, and poor maintenance of buildings used for manufacturing and raw material storage, leading to water damage. The findings indicate a moderate level of concern regarding the firm's adherence to good manufacturing practices.

## Related Documents

- [483 - 2023-03-31](https://www.keypedia.com/records/483/siegfried-evionnaz-sa/11728a7a-fedc-4e87-9060-e880c2f9eefc)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/siegfried-evionnaz-sa/80827909-f3d5-4745-bc93-14f265628c39

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1