# FDA 483 - MABXIENCE S.A.U. - April 07, 2025

Source: https://www.keypedia.com/records/483/mabxience-sau/674ad927-0fa5-4b16-8020-ef29c9106b47

> FDA 483 for MABXIENCE S.A.U. on April 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MABXIENCE S.A.U.
- Inspection Date: 2025-04-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of mAbxience S.A.U. in Garin, Argentina, revealed significant deficiencies in its drug substance manufacturing operations. The firm failed to optimize its manufacturing processes, leading to bioburden control issues, and exhibited inadequately maintained facilities and equipment. Furthermore, the inspection identified shortcomings in environmental control, validation activities, adherence to standard operating procedures, and laboratory controls, indicating a broad lack of control over critical quality systems.

## Related Officers

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Deborah H. Schmiel](https://www.keypedia.com/people/deborah-h-schmiel/facfc308-52af-4353-902a-0d45d5d88020)

Company: https://www.keypedia.com/companies/mabxience-sau/fe1d98c2-26cc-47eb-8caf-2c1368b5a1a4

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd