# FDA 483 - B. Braun Medical Inc - December 15, 2023

Source: https://www.keypedia.com/records/483/b-braun-medical-inc/20548a71-1584-4d2e-af2e-edba60893864

> FDA 483 for B. Braun Medical Inc on December 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Medical Inc
- Inspection Date: 2023-12-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of B. Braun Medical Inc. in Irvine, CA, revealed significant deficiencies in quality control and manufacturing practices. Observations included a failure to thoroughly investigate out-of-specification results for Heparin Sodium, inadequate annual product review procedures, and non-adherence to written testing protocols for subvisible particulate matter. These issues indicate a need for improved quality system oversight and procedural compliance at the sterile drug manufacturing facility.

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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