Sarati International, Inc FDA Record

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

Sarati International, Inc has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sarati International, Inc" is on file.

What these totals cover: FDA records filed under the name "Sarati International, Inc" and its spelling variant "Sarati International".

Latest inspection
Mar 21, 2025 · 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 actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

4 inspections from Aug 31, 2009 to Mar 21, 2025.

DateSiteProductClassificationFEI
Mar 21, 2025Los Fresnos, TXDrugsNo Action Indicated (NAI)3002979812
Nov 20, 2015Los Fresnos, TXDrugsNo Action Indicated (NAI)3002979812
Jun 29, 2011Los Fresnos, TXDrugsVoluntary Action Indicated (VAI)3002979812
Aug 31, 2009Los Fresnos, TXFood/CosmeticsNo Action Indicated (NAI)3002979812
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002979812Los Fresnos, TX4Mar 21, 2025

Sarati International, Inc and the FDA: common questions

Has Sarati International, Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Sarati International, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Sarati International, Inc received an FDA Form 483?

FDA has not published a Form 483 for "Sarati International, Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sarati International, Inc?

The most recent FDA inspection on file ended Mar 21, 2025 at Los Fresnos, TX and was classified NAI. FDA has 4 inspections of Sarati International, Inc on file.

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