# FDA 483 - B. Braun Medical Inc - June 29, 2018

Source: https://www.keypedia.com/records/483/b-braun-medical-inc/f2ded421-4e11-4121-acc6-e2d8ea7d7d5e

> FDA 483 for B. Braun Medical Inc on June 29, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: B. Braun Medical Inc
- Inspection Date: 2018-06-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: B. Braun Medical Inc. in Irvine, CA, a sterile drug manufacturer, received an FDA Form 483 citing significant deficiencies in laboratory controls and data integrity. Observations included incomplete laboratory records, manipulation of test data, inadequate computer system controls, and a failure to establish proper test method specificity and impurity specifications. These findings indicate serious concerns regarding the reliability of product quality testing and overall data management practices.

## Related Documents

- [483 - 2020-07-23](https://www.keypedia.com/records/483/b-braun-medical-inc/7a9223d9-42ec-4229-9715-32858f2788e6)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/b-braun-medical-inc/20548a71-1584-4d2e-af2e-edba60893864)
- [483 - 2025-11-21](https://www.keypedia.com/records/483/b-braun-medical-inc/4ef2fe5d-e907-456f-b54e-e3da8ce6e855)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [investigator](https://www.keypedia.com/people/amanda-l-fyles/4a00278a-a7c5-4751-a8b7-6c0ce2e24272)
- [Microbiology Scientific Coordinator](https://www.keypedia.com/people/evelyn-wong/76e6c539-cbb1-4d87-81b9-f115cc6e59a4)

Company: https://www.keypedia.com/companies/b-braun-medical-inc/7d193a37-e8a0-4f0f-aeea-f64ccd959191

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6