Chean Industries Dominicana S.R.L. FDA Record

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

Chean Industries Dominicana S.R.L. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Chean Industries Dominicana S.R.L., the most recent on Jul 10, 2023.

What these totals cover: FDA records filed under the name "Chean Industries Dominicana S.R.L." and its spelling variant "Chean Industries Dominicana".

Latest inspection
Mar 1, 2023 · OAI

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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Chean Industries Dominicana S.R.L. FDA Warning Letters

1 warning letter on Jul 10, 2023.

IssuedSubjectIssuing officeClose-out letter
Jul 10, 2023Seafood HACCP/CGMP for Foods/AdulteratedCenter for Food Safety and Applied Nutrition

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 Mar 1, 2023.

DateSiteProductClassificationFEI
Mar 1, 2023Santiago, Dominican Republic (The)Food/CosmeticsOfficial Action Indicated (OAI)3014058691
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 Chean Industries Dominicana S.R.L.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 10, 2023.

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 3014058691Santiago, Dominican Republic (The)1Mar 1, 2023

Chean Industries Dominicana S.R.L. and the FDA: common questions

Has Chean Industries Dominicana S.R.L. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Chean Industries Dominicana S.R.L.. The most recent is dated Jul 10, 2023, with the subject "Seafood HACCP/CGMP for Foods/Adulterated".

Has Chean Industries Dominicana S.R.L. received an FDA Form 483?

FDA has not published a Form 483 for "Chean Industries Dominicana S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Chean Industries Dominicana S.R.L.?

The most recent FDA inspection on file ended Mar 1, 2023 at Santiago, Dominican Republic (The) and was classified OAI. FDA has 1 inspection of Chean Industries Dominicana S.R.L. on file, 1 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.