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Hikma Farmaceutica, (Portugal) S.A. FDA Record

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

Latest inspection VAI · Apr 21, 2023
Last warning letter 2014

Inspections 9

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Oct 21, 2014

510(k) clearances 0 None on file

Hikma Farmaceutica, (Portugal) S.A. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Hikma Farmaceutica, (Portugal) S.A., the most recent on Oct 21, 2014.

What these totals cover: FDA records filed under the name "Hikma Farmaceutica, (Portugal) S.A." and its spelling variant "Hikma Farmaceutica, (Portugal)". They do not include records filed under Hikma Pharmaceuticals or other names in its corporate family; those are listed under Related names, each with its own counts.

Latest inspection: Apr 21, 2023 · VAI

Part of the Hikma Pharmaceuticals corporate family.

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	9	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hikma Farmaceutica, (Portugal) S.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Hikma Farmaceutica, (Portugal) S.A.: FDA inspections per year

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	2	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	1	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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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Hikma Farmaceutica, (Portugal) S.A. above. Hikma Pharmaceuticals is the parent company.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Hikma Pharmaceuticals	parent company	0	0	5	0	—

Hikma Farmaceutica, (Portugal) S.A. FDA Warning Letters

1 warning letter on Oct 21, 2014.

Issued	Subject	Issuing office	Close-out letter
Oct 21, 2014 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

9 inspections from Sep 24, 2009 to Apr 21, 2023.

Date	Site	Product	Classification	FEI
Apr 21, 2023	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Feb 3, 2023	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Mar 6, 2020	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Mar 22, 2018	Terrugem Snt, Portugal	Drugs	No Action Indicated (NAI)	3002807173
Apr 12, 2016	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Jun 19, 2015	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Mar 28, 2014	Terrugem Snt, Portugal	Drugs	Official Action Indicated (OAI)	3002807173
Sep 29, 2011	Terrugem Snt, Portugal	Drugs	Voluntary Action Indicated (VAI)	3002807173
Sep 24, 2009	Terrugem Snt, Portugal	Drugs	No Action Indicated (NAI)	3002807173

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 Hikma Farmaceutica, (Portugal) S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 21, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other 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 3002807173	Terrugem Snt, Portugal	9	Apr 21, 2023

Hikma Farmaceutica, (Portugal) S.A. and the FDA: common questions

Has Hikma Farmaceutica, (Portugal) S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Hikma Farmaceutica, (Portugal) S.A.. The most recent is dated Oct 21, 2014.

Has Hikma Farmaceutica, (Portugal) S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Hikma Farmaceutica, (Portugal) S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hikma Farmaceutica, (Portugal) S.A.?

The most recent FDA inspection on file ended Apr 21, 2023 at Terrugem Snt, Portugal and was classified VAI. FDA has 9 inspections of Hikma Farmaceutica, (Portugal) S.A. on file, 1 of them classified OAI (official action indicated).

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