Becton Dickinson, S.A.October 27, 2022

FDA 483 - Becton Dickinson, S.A. - October 27, 2022

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Record Details

An FDA inspection of Becton Dickinson, S.A. in San Agustin Del Guadalix, Madrid, Spain, from October 24-27, 2022, revealed two significant observations. The firm was cited for inadequately established procedures for environmental control, specifically concerning alert and action limits. Additionally, the inspection found deficiencies in the documentation of corrective and preventive action activities and their results.

Company: Becton Dickinson, S.A.
Inspection Date: October 27, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

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