# FDA 483 - Becton Dickinson Medical Systems - August 01, 2018

Source: https://www.keypedia.com/records/483/becton-dickinson-medical-systems/e80eabed-e962-49d8-a052-a2bfc9921133

> FDA 483 for Becton Dickinson Medical Systems on August 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson Medical Systems
- Inspection Date: 2018-08-01
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Becton Dickinson Medical Systems in Franklin, WI, was inspected for its manufacturing of sterile saline/heparin-filled syringes and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in environmental controls, contamination prevention, process validation, monitoring, and corrective and preventive actions, indicating a high risk of product contamination and quality issues.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/becton-dickinson-medical-systems/07d3bc1e-e0af-4167-83c3-8ad89f1a2f60

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669