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Facility profile

B. Braun US Pharmaceutical Manufacturing LLC

Testing & analysis · Drug product manufacturing · Irvine, CA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisLabelManufacturePackSterilize
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Nov 21, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2017

More than five years old · review later records.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history18 inspection records

FDA inspection history

18 records, Mar 2009 – Nov 2025 · 7 NAI · 8 VAI · 3 OAI

DateClassProject areaCitationsFY
Nov 21, 2025OAIDrug Quality AssuranceYes2026
Aug 6, 2024NAIBlood and Blood Products2024
Dec 15, 2023VAIDrug Quality AssuranceYes2024
Oct 13, 2023NAICompliance: Devices2024
Oct 13, 2023NAIPostmarket Assurance: Devices2024
Aug 17, 2021VAIDrug Quality Assurance2021
Jun 29, 2018OAIDrug Quality AssuranceYes2018
May 11, 2016OAIDrug Quality Assurance2016
Mar 3, 2015VAIDrug Quality AssuranceYes2015
Feb 13, 2014VAIDrug Quality AssuranceYes2014
Nov 13, 2013VAIDrug Quality Assurance2014
May 17, 2013VAIDrug Quality AssuranceYes2013
Mar 8, 2012VAIDrug Quality Assurance2012
Mar 21, 2011NAIDrug Quality Assurance2011
Mar 21, 2011NAICompliance: Devices2011
Mar 21, 2011NAIPostmarket Assurance: Devices2011
Sep 22, 2010NAIDrug Quality Assurance2010
Mar 5, 2009VAIDrug Quality Assurance2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

May 12, 2017Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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