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Fareva Unterach GmbH

FDA Regulatory Profile

Fareva Unterach GmbH has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Fareva Unterach GmbH" and its spelling variant "Fareva Unterach".

Latest inspection: Jun 2, 2022 · VAI

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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	7	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Fareva Unterach GmbH'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	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	2	0	0	0	0
2018	0	0	0	0	0
2017	0	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

7 inspections from Mar 12, 2010 to Jun 2, 2022.

Date	Site	Product	Classification	FEI
Jun 2, 2022	Unterach Am Attersee, Austria	Drugs	Voluntary Action Indicated (VAI)	3002829723
Jul 10, 2019	Unterach Am Attersee, Austria	Drugs	Voluntary Action Indicated (VAI)	3002829723
May 8, 2019	Unterach Am Attersee, Austria	Drugs	Voluntary Action Indicated (VAI)	3002829723
Dec 18, 2014	Unterach Am Attersee, Austria	Drugs	No Action Indicated (NAI)	3002829723
Oct 23, 2012	Unterach Am Attersee, Austria	Drugs	Official Action Indicated (OAI)	3002829723
Jul 25, 2011	Unterach Am Attersee, Austria	Drugs	Voluntary Action Indicated (VAI)	3002829723
Mar 12, 2010	Unterach Am Attersee, Austria	Drugs	Voluntary Action Indicated (VAI)	3002829723

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Fareva Unterach GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 28, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002829723	Unterach Am Attersee, Austria	7	Jun 2, 2022

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