# FDA 483 - Bioiberica, SAU - February 04, 2022

Source: https://www.globalkeysolutions.net/records/483/bioiberica-sau/06b6af77-42eb-4d12-87b3-3eda2ea580f1

> FDA 483 for Bioiberica, SAU on February 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioiberica, SAU
- Inspection Date: 2022-02-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bioiberica, S.A.U's drug substance manufacturing facility in Palafolls, Barcelona, revealed significant deficiencies across multiple areas. The firm was cited for inadequate cleaning validation, uncontrolled reprocessing procedures, and a quality control unit that failed to ensure data integrity and proper test method verification. Additionally, the inspection found a lack of a written stability testing program and insufficient investigation follow-up for unexplained discrepancies.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/bioiberica-sau/3984e671-30b1-4c37-b603-0e20b5a76b7d

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