# FDA 483 - UCB Farchim SA - July 04, 2023

Source: https://www.globalkeysolutions.net/records/483/ucb-farchim-sa/98345518-36a4-4fc7-b67a-f8590d2595d3

> FDA 483 for UCB Farchim SA on July 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCB Farchim SA
- Inspection Date: 2023-07-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: UCB Farchim SA, a drug substance and bulk drug product manufacturer in Bulle, Switzerland, received a Form 483 with significant findings. The inspection revealed critical deficiencies in quality unit oversight, particularly concerning electronic data integrity, control over computerized systems, and the validation of test methods. Additionally, the firm lacked adequate written procedures for handling components during material receipt.

## Related Documents

- [483 - 2023-07-04](https://www.globalkeysolutions.net/records/483/ucb-farchim-sa/b96d12cb-cd84-43fc-9214-aa1f83757477)

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/ucb-farchim-sa/07bb62e5-701c-4c7c-b3a4-39064909c9f1

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