Fresh Directions Dominicana S.A. FDA Record

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

Fresh Directions Dominicana 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 Fresh Directions Dominicana S.A., the most recent on Nov 25, 2013.

What these totals cover: FDA records filed under the name "Fresh Directions Dominicana S.A." and its spelling variant "Fresh Directions Dominicana".

Latest inspection
May 30, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Fresh Directions Dominicana S.A. FDA Warning Letters

1 warning letter on Nov 25, 2013.

IssuedSubjectIssuing officeClose-out letter
Nov 25, 2013 · 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

4 inspections from Jun 21, 2013 to May 30, 2023.

DateSiteProductClassificationFEI
May 30, 2023San Cristobal, Dominican Republic (The)Food/CosmeticsNo Action Indicated (NAI)3004146490
Nov 21, 2016San Cristobal, Dominican Republic (The)Food/CosmeticsVoluntary Action Indicated (VAI)3004146490
May 21, 2015San Cristobal, Dominican Republic (The)Food/CosmeticsOfficial Action Indicated (OAI)3004146490
Jun 21, 2013San Cristobal, Dominican Republic (The)Food/CosmeticsOfficial Action Indicated (OAI)3004146490
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 Fresh Directions Dominicana S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 25, 2013.

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.

FacilityLocationInspectionsLatest
FEI 3004146490San Cristobal, Dominican Republic (The)4May 30, 2023

Fresh Directions Dominicana S.A. and the FDA: common questions

Has Fresh Directions Dominicana S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Fresh Directions Dominicana S.A.. The most recent is dated Nov 25, 2013.

Has Fresh Directions Dominicana S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Fresh Directions Dominicana S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fresh Directions Dominicana S.A.?

The most recent FDA inspection on file ended May 30, 2023 at San Cristobal, Dominican Republic (The) and was classified NAI. FDA has 4 inspections of Fresh Directions Dominicana S.A. on file, 2 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.