# FDA 483 - Becton Dickinson & Co. - April 11, 2025

Source: https://www.keypedia.com/records/483/becton-dickinson-co/0a841f48-f79f-4343-9a6e-0930bcdefef8

> FDA 483 for Becton Dickinson & Co. on April 11, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Becton Dickinson & Co.
- Inspection Date: 2025-04-11
- Product Type: device
- Office Name: Baltimore District Office
- Summary: Becton Dickinson & Co. in Sparks, MD, a medical device manufacturer, was cited for significant deficiencies in its Medical Device Reporting (MDR) and complaint handling processes. The firm failed to submit required MDRs by combining multiple customer-reported events into single records, leading to under-reporting of potential serious injuries or malfunctions. Additionally, procedures for receiving and evaluating complaints were found to be inadequate due to this practice of comingling distinct events.

## Related Documents

- [483 - 2021-07-23](https://www.keypedia.com/records/483/becton-dickinson-co/d7a5ae09-1b7a-4536-8200-45a6534aedf3)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/becton-dickinson-co/bbd4a72e-1db2-42b3-9c50-1c857692c743

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa