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

Source: https://www.globalkeysolutions.net/records/483/ucb-farchim-sa/b96d12cb-cd84-43fc-9214-aa1f83757477

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

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## Details

- Record Type: 483
- Company Name: UCB Farchim SA
- Inspection Date: 2023-07-04
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's quality unit oversight, data integrity, and control over electronic and physical records.

**Key Observations:**

*   **Deficient Quality Unit Oversight:** The Quality Unit's oversight of quality control operations, including laboratory and production electronic systems and data review, is inadequate.
*   **Data Integrity Program Lacking:** There is no adequate data integrity program, specifically a statistically sound sampling plan for the Quality Assurance (QA) Unit to review all electronic data (chromatographic and non-chromatographic) for completeness, consistency, and accuracy. Only analysts verify laboratory work, with QA confirming QC review, but no electronic data is reviewed by QA.
*   **Lack of Control Over Electronic Records:** QA and QC personnel can delete data from desktops, making it unrecoverable, as observed during the inspection. While file names are retained for six months, the documents themselves cannot be restored.
*   **Inadequate Control Over Manufacturing Batch Records:** Manufacturing batch records issued to production lack unique identifiers, allowing for unauthorized copies to be made outside the document control system.
*   **Insufficient Computer System Controls:** Appropriate controls are not exercised over computers or related systems to ensure changes in laboratory control records are instituted only by authorized personnel.
*   **Unvalidated/Unqualified Computerized Systems:** GMP-related computerized systems and equipment, such as Empower 3 software, have not been

## Related Documents

- [483 - 2023-07-04](https://www.globalkeysolutions.net/records/483/ucb-farchim-sa/98345518-36a4-4fc7-b67a-f8590d2595d3)

## 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-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe