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Manufacturing facility

Isomedix Operations 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
2500 Commerce Dr, Libertyville, Illinois (IL) 60048, United States (USA)
Operations here
sterilize
FDA identifiers
FEI 3003015552 · DUNS 004303926

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIHuman Cellular, Tissue, and Gene Therapies2026-01-27
  • VAIDrug Quality Assurance2023-09-18
  • NAIHuman Cellular, Tissue, and Gene Therapies2017-01-09
  • VAIDrug Quality Assurance2015-12-03
  • VAIHuman Cellular, Tissue, and Gene Therapies2015-12-03
  • NAIDrug Quality Assurance2012-09-28
  • NAIHuman Cellular, Tissue, and Gene Therapies2012-09-28
  • NAIDrug Quality Assurance2011-01-24
  • NAIHuman Cellular, Tissue, and Gene Therapies2011-01-24
  • NAIDrug Quality Assurance2009-12-02
  • NAIDrug Quality Assurance2009-06-24

Drugs this plant is listed as making

1 distinct drugs across 2 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.