# FDA 483 - NAMSA - February 18, 2008

Source: https://www.globalkeysolutions.net/records/483/namsa/26671a67-13f2-4f89-a817-ea11f9692e5a

> FDA 483 for NAMSA on February 18, 2008. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NAMSA
- Inspection Date: 2008-02-18
- Product Type: other
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Biomatech, SAS, a contract testing laboratory in Chasse-sur-Rhone, France, revealed significant quality system deficiencies. The firm failed to complete out-of-specification investigations before reporting results, maintain adequate testing documentation, and properly investigate unexpected animal deaths. Additionally, issues were noted with computer system controls and the establishment of variance limits for testing parameters.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/namsa/427ba674-2474-46b5-bb65-f547a2a9cca2)

## Related Officers

- [CSO](https://www.globalkeysolutions.net/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)
- [Cynthia Jha, CSO](https://www.globalkeysolutions.net/people/cynthia-jha-cso/65b65428-79da-4c40-8da0-be6116e95edf)

Company: https://www.globalkeysolutions.net/companies/namsa/75e0a630-1969-447d-8b12-7ed05ebc324f

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