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Mappel Industria De Embalagens S.A. FDA Record

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

Mappel Industria De Embalagens S.A. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Mappel Industria De Embalagens S.A., the most recent on Sep 12, 2016.

What these totals cover: FDA records filed under the name "Mappel Industria De Embalagens S.A." and its spelling variant "Mappel Industria De Embalagens".

Latest inspection: Apr 15, 2016 · OAI

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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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Mappel Industria De Embalagens S.A. FDA Warning Letters

1 warning letter on Sep 12, 2016.

Issued	Subject	Issuing office	Close-out letter
Sep 12, 2016

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

1 inspection on Apr 15, 2016.

Date	Site	Product	Classification	FEI
Apr 15, 2016	Diadema, Brazil	Drugs	Official Action Indicated (OAI)	3010462471

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 Mappel Industria De Embalagens S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 12, 2016.

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 3010462471	Diadema, Brazil	1	Apr 15, 2016

Mappel Industria De Embalagens S.A. and the FDA: common questions

Has Mappel Industria De Embalagens S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Mappel Industria De Embalagens S.A.. The most recent is dated Sep 12, 2016.

Has Mappel Industria De Embalagens S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Mappel Industria De Embalagens S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mappel Industria De Embalagens S.A.?

The most recent FDA inspection on file ended Apr 15, 2016 at Diadema, Brazil and was classified OAI. FDA has 1 inspection of Mappel Industria De Embalagens S.A. on file, 1 of them classified OAI (official action indicated).

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