FDA 483 - UCB Farchim SA - July 04, 2023

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