FDA 483 to UCB Switzerland cite gaps in Data Integrity program, lack of Quality oversight Read More..

USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA. The site was inspected by USFDA investigator Arsen Karapetyan in June / July 2023 and resulted in issuance of FDA Form 483 with four observations. The observations cite deficiencies, some of which are basic cGMP disciplines to be practiced in Pharma.

1. Inadequate Quality oversight over Quality control (QC) operations and Gap in Data Integrity program

Interrupted chromatographic runs are not documented, evaluated, chromatographic runs are manually aborted/interrupted; No systems and processes for electronic data review in QC, QA/QC personnel can delete data irrevocably from desktops, no systems /unique identifiers on batch records to prevent generation of additional copies

• Inadequate control over GxP computer systems –

Interrupted chromatographic sequences, errors like Data Incomplete, Missing data errors in Empower 3 software, Firm lack understanding of different types of communication errors in computerised systems

• Deficiencies in Method transfers, method verifications –

 Method transfers not performed for APIs, standard and sample solution stabilities are not established for HPLC methods.

• Material receipt and handling procedures in the Warehouse are inadequate

USFDA 483