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Manufacturing facility

Xttrium Laboratories, Inc.

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
1200 E. Business Center Drive, Mount Prospect, Illinois (IL) 60056, United States (USA)
Operations here
api manufacturelabelmanufacturepack
FDA identifiers
FEI 3008436464 · DUNS 007470579

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 9 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 Assurance2025-06-18
  • VAIDrug Quality Assurance2024-03-08
  • NAIBioresearch Monitoring2024-02-06
  • VAIDrug Quality Assurance2018-03-15
  • VAIDrug Quality Assurance2016-07-11
  • VAIBioresearch Monitoring2016-05-25
  • VAIDrug Quality Assurance2013-12-05
  • NAIBioresearch Monitoring2013-01-15
  • NAIDrug Quality Assurance2012-12-11
  • NAIDrug Quality Assurance2011-10-20
  • VAIDrug Quality Assurance2011-07-18
  • VAIPostmarket Surv. and Epidemiology2011-07-18
  • NAIDrug Quality Assurance2010-07-16
  • VAIDrug Quality Assurance2010-02-19
  • NAIDrug Quality Assurance2009-08-20
  • OAIDrug Quality Assurance2008-12-31

Drugs this plant is listed as making

9 distinct drugs across 17 products name this site in their FDA label.

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.