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Union Quimico Farmaceutica SA FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Union Quimico Farmaceutica SA has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Union Quimico Farmaceutica SA" is on file.

What these totals cover: FDA records filed under the name "Union Quimico Farmaceutica SA" and its spelling variant "Union Quimico Farmaceutica".

Latest inspection: Jul 7, 2022 · VAI

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	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Union Quimico Farmaceutica SA'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	1	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.

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Recent FDA inspections

4 inspections from Jun 18, 2009 to Jul 7, 2022.

Date	Site	Product	Classification	FEI
Jul 7, 2022	Sant Celoni, Spain	Drugs	Voluntary Action Indicated (VAI)	3002808431
Mar 1, 2019	Sant Celoni, Spain	Drugs	Voluntary Action Indicated (VAI)	3002808431
May 15, 2015	Sant Celoni, Spain	Drugs	No Action Indicated (NAI)	3002808431
Jun 18, 2009	Sant Celoni, Spain	Drugs	Voluntary Action Indicated (VAI)	3002808431

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 3002808431	Sant Celoni, Spain	4	Jul 7, 2022

Union Quimico Farmaceutica SA and the FDA: common questions

Has Union Quimico Farmaceutica SA received an FDA warning letter?

No FDA warning letter addressed to the name "Union Quimico Farmaceutica SA" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Union Quimico Farmaceutica SA received an FDA Form 483?

FDA has not published a Form 483 for "Union Quimico Farmaceutica SA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Union Quimico Farmaceutica SA?

The most recent FDA inspection on file ended Jul 7, 2022 at Sant Celoni, Spain and was classified VAI. FDA has 4 inspections of Union Quimico Farmaceutica SA on file.

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