Fresenius Medical Care North America
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
- 475 West 13th Street, Ogden, Utah (UT) 84404, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 1713747 · DUNS 078401205
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 2 drugs. 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 Assurance2026-03-06
- VAIDrug Quality Assurance2021-05-21
- VAIDrug Quality Assurance2020-08-13
- VAIDrug Quality Assurance2017-08-18
- VAIDrug Quality Assurance2014-01-10
- VAIDrug Quality Assurance2012-03-08
- VAIDrug Quality Assurance2011-02-04
- NAIDrug Quality Assurance2009-06-12
Drugs this plant is listed as making
2 distinct drugs across 11 products name this site in their FDA label.
- Sodium ChlorideFresenius Kabi USA, LLC
- Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium ChlorideBecton Dickinson and Company
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.