# FDA 483 - Becton Dickinson Infusion Therapy Systems, Inc. - March 26, 2026

Source: https://www.keypedia.com/records/483/becton-dickinson-infusion-therapy-systems-inc/9809fe07-7e09-4ff9-995c-f64dec8c5643

> FDA 483 for Becton Dickinson Infusion Therapy Systems, Inc. on March 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Becton Dickinson Infusion Therapy Systems, Inc.
- Inspection Date: 2026-03-26
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Becton Dickinson Infusion Therapy Systems, Inc. in Sandy, UT, was cited for significant deficiencies in quality control, equipment cleaning, and microbial control during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results, releasing affected drug products, and demonstrated inadequate cleaning validation and maintenance practices for manufacturing equipment. Additionally, procedures to prevent objectionable microorganisms in non-sterile drug products were not adequately established, particularly concerning bulk solution hold time studies.

## Related Documents

- [483 - 2018-12-14](https://www.keypedia.com/records/483/becton-dickinson-infusion-therapy-systems-inc/86aba4aa-f1be-459b-8581-5e7cfea0b652)

## Related Officers

- [Investigator](https://www.keypedia.com/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/becton-dickinson-infusion-therapy-systems-inc/d0e73e32-eca1-4137-8dfc-d6bde32ba0aa

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face