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Laboratorios Dentales De Zona Franca, S.A. FDA Record

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

Latest inspection OAI · Jan 30, 2020
Last warning letter 2020

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 15, 2020

510(k) clearances 0 None on file

Laboratorios Dentales De Zona Franca, 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 Laboratorios Dentales De Zona Franca, S.A., the most recent on May 15, 2020.

What these totals cover: FDA records filed under the name "Laboratorios Dentales De Zona Franca, S.A." and its spelling variant "Laboratorios Dentales De Zona Franca".

Latest inspection: Jan 30, 2020 · 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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Laboratorios Dentales De Zona Franca, S.A. FDA Warning Letters

1 warning letter on May 15, 2020.

Issued	Subject	Issuing office	Close-out letter
May 15, 2020 · Letter on fda.gov		Center for Devices and Radiological Health

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 Jan 30, 2020.

Date	Site	Product	Classification	FEI
Jan 30, 2020	San Isidro Del Guarco, Costa Rica	Devices	Official Action Indicated (OAI)	3001295407

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 Laboratorios Dentales De Zona Franca, S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 15, 2020.

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 3001295407	San Isidro Del Guarco, Costa Rica	1	Jan 30, 2020

Laboratorios Dentales De Zona Franca, S.A. and the FDA: common questions

Has Laboratorios Dentales De Zona Franca, S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Laboratorios Dentales De Zona Franca, S.A.. The most recent is dated May 15, 2020.

Has Laboratorios Dentales De Zona Franca, S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Laboratorios Dentales De Zona Franca, S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Laboratorios Dentales De Zona Franca, S.A.?

The most recent FDA inspection on file ended Jan 30, 2020 at San Isidro Del Guarco, Costa Rica and was classified OAI. FDA has 1 inspection of Laboratorios Dentales De Zona Franca, S.A. on file, 1 of them classified OAI (official action indicated).

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