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

Source: https://www.keypedia.com/records/483/becton-dickinson-sa/6eee971b-a2b7-42e3-8b71-6004a2dc2c81

> FDA 483 for Becton Dickinson, S.A. on October 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson, S.A.
- Inspection Date: 2022-10-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/becton-dickinson-sa/4ef6d251-95f8-4ead-8e2e-452ca280fee0

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