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Manufacturing facility

Jubilant HollisterStier General Partnership

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
Canada
Registered address
16751 Trans-Canada Highway, Kirkland, Quebec H9H 4J4, Canada (CAN)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 3001623073 · DUNS 246762764

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. 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 Assurance2025-11-03
  • OAIDrug Quality Assurance2024-06-14
  • NAIBioresearch Monitoring2022-10-07
  • VAIDrug Quality Assurance2018-06-01
  • VAIDrug Quality Assurance2015-12-10
  • VAIDrug Quality Assurance2013-09-26
  • OAIDrug Quality Assurance2012-03-26
  • NAIDrug Quality Assurance2010-02-11
  • NAIDrug Quality Assurance2009-02-05

Drugs this plant is listed as making

9 distinct drugs across 12 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.