B. Braun US Pharmaceutical Manufacturing LLC
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 2525 McGaw Avenue, Irvine, California (CA) 92614, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 2021236 · DUNS 037425308
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 5 drugs, 1 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-11-21
- NAIBlood and Blood Products2024-08-06
- VAIDrug Quality Assurance2023-12-15
- VAIDrug Quality Assurance2021-08-17
- OAIDrug Quality Assurance2018-06-29
- OAIDrug Quality Assurance2016-05-11
- VAIDrug Quality Assurance2015-03-03
- VAIDrug Quality Assurance2014-02-13
- VAIDrug Quality Assurance2013-11-13
- VAIDrug Quality Assurance2013-05-17
- VAIDrug Quality Assurance2012-03-08
- NAIDrug Quality Assurance2011-03-21
- NAIDrug Quality Assurance2010-09-22
- VAIDrug Quality Assurance2009-03-05
Drugs this plant is listed as making
5 distinct drugs across 8 products name this site in their FDA label.
- Dextrosein shortageB. Braun Medical Inc.
- LevetiracetamB. Braun Medical Inc.
- Sodium ChlorideB. Braun Medical Inc.
- Sodium Chloride for IrrigationB. Braun Medical Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.