# FDA 483 - Biosphere Medical S.A. - July 26, 2026

Source: https://www.keypedia.com/records/483/biosphere-medical-sa/235d777e-d54e-4794-a7d8-a7f143d13e8c

> FDA 483 for Biosphere Medical S.A. on July 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biosphere Medical S.A.
- Inspection Date: 2026-07-26
- Product Type: device
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Biosphere Medical S.A., a medical device manufacturer in Louvres, France, from July 26-29, 1999, revealed significant quality system deficiencies. The firm failed to adequately validate sterilization processes for its Embospheres product and its packaging, and lacked proper procedures for environmental controls and design verification. Additionally, issues were noted in process validation documentation and the completeness and execution of quality audits.

## Related Officers

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Company: https://www.keypedia.com/companies/biosphere-medical-sa/89714a38-ea36-4031-a8f6-68540f5724e6

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4