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EUROAPI — Budapest

Budapest, Hungary · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
EUROAPI
Name(s) in FDA data
EuroAPI Hungary Ltd.
FEI number(s)
3002806675 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Budapest, Hungary
Records matched
5 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
21 Jun 2019 — NAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …Budapest | Hungary API PRODUCING & DEVELOPMENT CENTER (CHEMISTRY) 40+ APIs 180+ Customers served 40+ countries s…
  • Highly potent (HPAPI)
    …purpose chemical site Development center from kilo-lab to large pilot Strong expertise in high potency products (OEB5) and prostaglandines Industrial scale production for a comprehensive range…

Taken from the part of the company's network/locations page that describes this site. Source: https://www.euroapi.com/en/industrial-footprint, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 21 Jun 2019
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002806675, inspection ID 1098971)

  2. 20 Apr 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806675, inspection ID 1087962)

  3. 03 Mar 2017
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.194(a)(5): Calculations performed are in the records
    • 21 CFR 211.194(a): Complete test data included in records

    Source: FDA Data Dashboard – Citations (FEI 3002806675, inspection ID 1007848)

  4. 03 Mar 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002806675, inspection ID 1007848)

  5. 30 May 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3002806675, inspection ID 883136)

  6. 04 Feb 2010
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806675, inspection ID 645825)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.