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EuroAPI Hungary Ltd.

FDA Regulatory Profile

EuroAPI Hungary Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "EuroAPI Hungary Ltd." and its spelling variant "Euroapi Hungary".

Latest inspection: Jun 21, 2019 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

EuroAPI Hungary Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	1	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

5 inspections from Feb 4, 2010 to Jun 21, 2019.

Date	Site	Product	Classification	FEI
Jun 21, 2019	Budapest, Hungary	Veterinary	No Action Indicated (NAI)	3002806675
Apr 20, 2018	Budapest, Hungary	Drugs	Voluntary Action Indicated (VAI)	3002806675
Mar 3, 2017	Budapest, Hungary	Veterinary	Voluntary Action Indicated (VAI)	3002806675
May 30, 2014	Budapest, Hungary	Veterinary	No Action Indicated (NAI)	3002806675
Feb 4, 2010	Budapest, Hungary	Drugs	No Action Indicated (NAI)	3002806675

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002806675	Budapest, Hungary	5	Jun 21, 2019

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