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Laboratorio Magnachem International, S.A. FDA Record

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

Laboratorio Magnachem International, S.A. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Laboratorio Magnachem International, S.A., the most recent on Jun 18, 2024.

What these totals cover: FDA records filed under the name "Laboratorio Magnachem International, S.A." and its spelling variant "Laboratorio Magnachem International".

Latest inspection: Nov 10, 2023 · OAI

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	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Laboratorio Magnachem International, S.A.'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
2026	0	0	0
2025	0	0	0
2024	0	0	1
2023	1	1	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	0
2017	1	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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Laboratorio Magnachem International, S.A. FDA Warning Letters

1 warning letter on Jun 18, 2024.

Issued	Subject	Issuing office	Close-out letter
Jun 18, 2024 · Letter on fda.gov	CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated	Center for Drug Evaluation and Research \| CDER

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

4 inspections from Apr 27, 2012 to Nov 10, 2023.

Date	Site	Product	Classification	FEI
Nov 10, 2023	Haina, Dominican Republic (The)	Drugs	Official Action Indicated (OAI)	3003320065
Jun 2, 2017	Haina, Dominican Republic (The)	Drugs	Voluntary Action Indicated (VAI)	3003320065
Sep 16, 2014	Haina, Dominican Republic (The)	Drugs	Voluntary Action Indicated (VAI)	3003320065
Apr 27, 2012	Haina, Dominican Republic (The)	Drugs	Voluntary Action Indicated (VAI)	3003320065

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 Laboratorio Magnachem International, S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 21, 2024.

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 3003320065	Haina, Dominican Republic (The)	4	Nov 10, 2023

Laboratorio Magnachem International, S.A. and the FDA: common questions

Has Laboratorio Magnachem International, S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Laboratorio Magnachem International, S.A.. The most recent is dated Jun 18, 2024, with the subject "CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated".

Has Laboratorio Magnachem International, S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Laboratorio Magnachem International, S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Laboratorio Magnachem International, S.A.?

The most recent FDA inspection on file ended Nov 10, 2023 at Haina, Dominican Republic (The) and was classified OAI. FDA has 4 inspections of Laboratorio Magnachem International, S.A. on file, 1 of them classified OAI (official action indicated).

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