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Manufacturing facility

Ansto

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
Australia
Registered address
New Illawarra Road, Lucas Heights, New South Wales 2234, Australia (AUS)
Operations here
analysislabelmanufacturepackrelabelrepack
FDA identifiers
FEI 3002724726 · DUNS 750911232

FDA inspection history

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

  • NAIDrug Quality Assurance2022-06-24
  • NAIDrug Quality Assurance2016-02-04
  • NAIDrug Quality Assurance2009-08-14

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.