# FDA 483 - Corden Pharma Fribourg SA - February 03, 2023

Source: https://www.keypedia.com/records/483/corden-pharma-fribourg-sa/3a01de4a-ae1d-4a69-97a4-e83db8b94ead

> FDA 483 for Corden Pharma Fribourg SA on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corden Pharma Fribourg SA
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Corden Pharma Fribourg SA, a pharmaceutical manufacturer in Villars-sur-Glane, Switzerland, revealed significant deficiencies in their quality control processes. The firm failed to thoroughly investigate out-of-specification results and unexplained discrepancies, and their annual product reviews lacked adequate discussion of significant product variability. These issues indicate a need for improved quality system oversight.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/corden-pharma-fribourg-sa/749b4152-5491-45ed-8d48-4e05eeb96606

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