# FDA 483 - B. Braun Medical Inc - July 23, 2020

Source: https://www.globalkeysolutions.net/records/483/b-braun-medical-inc/7a9223d9-42ec-4229-9715-32858f2788e6

> FDA 483 for B. Braun Medical Inc on July 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Medical Inc
- Inspection Date: 2020-07-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of B. Braun Medical Inc. in Irvine, CA, a sterile drug manufacturer, revealed significant deficiencies in its quality control unit. The firm has multiple long-standing corrective and preventive actions (CAPAs) that remain incomplete, some dating back to a 2017 Warning Letter and a 2018 FDA-483. Additionally, investigations into out-of-specification (OOS) sterility test results were found to be inadequate, lacking proper follow-up and retraining, and critical equipment surfaces were observed to be worn, potentially compromising drug product quality.

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## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Uttaniti Limchumroon](https://www.globalkeysolutions.net/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

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

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