# FDA 483 - Becton Dickinson, S.A. - December 07, 2018

Source: https://www.keypedia.com/records/483/becton-dickinson-sa/1f84affd-028b-4719-ac5c-64ee759132f8

> FDA 483 for Becton Dickinson, S.A. on December 07, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson, S.A.
- Inspection Date: 2018-12-07
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Becton Dickinson, S.A., a contract sterilizer located in Fraga, Spain, received a Form FDA 483 following an inspection. The primary finding concerned a failure to adequately validate processes, specifically related to testing conducted for their PhaSeal product. This indicates a significant deficiency in the firm's quality system regarding process control and verification.

## Related Officers

- [Ashley A. Mutawakkil](https://www.keypedia.com/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.keypedia.com/companies/becton-dickinson-sa/14fd5d6c-0e33-4917-8d8a-f97a92a52767

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