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Manufacturing facility

Particle Analytical ApS

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
Denmark
Registered address
Agern Alle 3, Hoersholm, - 2970, Denmark (DNK)
Operations here
analysis
FDA identifiers
FEI 3007704654 · DUNS 306081360

FDA inspection history

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

  • VAIDrug Quality Assurance2025-01-09
  • NAIDrug Quality Assurance2021-08-19
  • NAIDrug Quality Assurance2018-09-27
  • NAIDrug Quality Assurance2015-07-20
  • NAIDrug Quality Assurance2009-09-14

Drugs this plant is listed as making

1 distinct drugs across 1 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.