# FDA 483 - Bioiberica, SAU - September 13, 2024

Source: https://www.globalkeysolutions.net/records/483/bioiberica-sau/183571fe-a614-4e7f-82d1-c38d1b9a58b4

> FDA 483 for Bioiberica, SAU on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioiberica, SAU
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bioiberica, SAU's drug substance manufacturing facility in Palafolls, Spain, revealed significant deficiencies. Observations included a lack of quality unit oversight for maintenance, inadequate equipment cleaning leading to material residue, and insufficient review of deviations and out-of-specification results. Additionally, the firm failed to fully validate laboratory test procedures for pyrogens and total microbial limit tests, specifically for endotoxin release testing.

## Related Documents

- [483 - 2022-02-04](https://www.globalkeysolutions.net/records/483/bioiberica-sau/87ebd3f5-e309-41d7-9704-f7eeaa8f87d3)
- [483 - 2022-02-04](https://www.globalkeysolutions.net/records/483/bioiberica-sau/06b6af77-42eb-4d12-87b3-3eda2ea580f1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

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