Becton Dickinson, S.A.December 7, 2018

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

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Record Details

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.

Company: Becton Dickinson, S.A.
Inspection Date: December 7, 2018
Product Type: Other
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Ashley A. Mutawakkil

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ID · 1f84affd-028b-4719-ac5c-64ee759132f8