Otsuka ICU Medical 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
- 3900 Howard Ln, Austin, Texas (TX) 78728, United States (USA)
- Operations here
- analysislabelmanufacturepackrepack
- FDA identifiers
- FEI 1628454 · DUNS 117395980
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBlood and Blood Products2024-06-28
- VAIDrug Quality Assurance2017-03-10
- VAIDrug Quality Assurance2014-05-23
- VAIDrug Quality Assurance2012-08-24
- OAIDrug Quality Assurance2011-04-27
- NAIDrug Quality Assurance2009-12-11
Drugs this plant is listed as making
5 distinct drugs across 12 products name this site in their FDA label.
- dextrose monohydratein shortageICU Medical, Inc.
- DEXTROSE MONOHYDRATE and SODIUM CHLORIDEICU Medical Inc.
- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.
- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATEICU Medical Inc.
- waterin shortageICU 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.