# FDA 483 - Rivopharm S.A. - January 18, 2019

Source: https://www.keypedia.com/records/483/rivopharm-sa/392efa75-cb07-454d-9c3a-31372ef740d2

> FDA 483 for Rivopharm S.A. on January 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rivopharm S.A.
- Inspection Date: 2019-01-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Rivopharm S.A. in Manno, Switzerland, the FDA observed a significant issue related to quality control procedures. The firm failed to ensure that changes to written procedures, specifically regarding equipment recipes and process parameters, were adequately reviewed and approved by the quality control unit. This indicates a lack of robust change control and process validation oversight.

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- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.keypedia.com/companies/rivopharm-sa/7cc8f5f7-352e-451c-bd6f-5abaec132ce0

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