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•United States

B. Braun Medical Inc, Irvine, CA – FDA Inspections

Inspection records and compliance data for B. Braun Medical Inc in Irvine, California. 15 FDA inspections on record (3 OAI), 3 Form 483s, last inspected November 21, 2025.

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Company Profile

This profile covers B. Braun Medical Inc based in Irvine, California, United States.

FDA Inspection History

FDA inspections
15
OAI
3
VAI
8
NAI
4
Form 483s
3
Warning letters
0

First inspected March 5, 2009. Last inspected November 21, 2025.

Most cited issue areas

  • Investigations of discrepancies, failures5 inspections
  • Cleaning / Sanitizing / Maintenance2 inspections
  • Contamination, chemical or physical change, deterioration2 inspections

FDA inspections (15)

DateResultFDA center(s)Insp. #
November 21, 2025OAIHuman Drugs · Drug Quality Assurance1292536
August 6, 2024NAIBiologics · Blood and Blood Products1231010
December 15, 2023VAIHuman Drugs · Drug Quality Assurance1226163
October 13, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1222593
August 17, 2021VAIHuman Drugs · Drug Quality Assurance1152417
June 29, 2018OAIHuman Drugs · Drug Quality Assurance1057639
May 11, 2016OAIHuman Drugs · Drug Quality Assurance975174
March 3, 2015VAIHuman Drugs · Drug Quality Assurance917536
February 13, 2014VAIHuman Drugs · Drug Quality Assurance866672
November 13, 2013VAIHuman Drugs · Drug Quality Assurance857657
May 17, 2013VAIHuman Drugs · Drug Quality Assurance833727
March 8, 2012VAIHuman Drugs · Drug Quality Assurance771376
March 21, 2011NAIHuman Drugs, Medical Devices & Rad Health · Compliance: Devices719883
September 22, 2010NAIHuman Drugs · Drug Quality Assurance682057
March 5, 2009VAIHuman Drugs · Drug Quality Assurance569846
FDA documents

Form 483s (4)

  • Form 483s · November 21, 2025
  • Form 483s · December 15, 2023
  • Form 483s · July 23, 2020
  • Form 483s · June 29, 2018

EIRs (1)

  • EIRs · May 11, 2016
People (5)
Jeffery Huth
Person
Evelyn Wong
Person
Amanda L. Fyles
Person
Walden H. Lee
Person
Uttaniti Limchumroon
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

CareFusion 213, LLC
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Terumo BCT Ltd
Fresenius Medical Care, North America
Patheon Italia S.p.A.
Glenmark Pharmaceuticals Inc USA
ENDO Pharmaceuticals Solutions, Inc.
Aspen SA Sterile Operations (Pty) Ltd.
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Gland Chemical Private Limited
Company Information

Name

B. Braun Medical Inc

FEI Number

2021236

Address

2525 Mcgaw Ave, Irvine, California 92614, United States

Country

United States

ID: 7d193a37-e8a0-4f0f-aeea-f64ccd959191

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