PT. Intimas Surya

FDA Regulatory Profile

PT. Intimas Surya has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 2 compliance actions on record.

What these totals cover: FDA records filed under the name "PT. Intimas Surya".

Latest inspection
Sep 14, 2017 · NAI

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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 13, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

4 inspections from Oct 15, 2010 to Sep 14, 2017.

DateSiteProductClassificationFEI
Sep 14, 2017Denpasar, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3004329628
Jul 27, 2017Jakarta, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3004254617
May 25, 2011Jakarta, IndonesiaFood/CosmeticsOfficial Action Indicated (OAI)3004254617
Oct 15, 2010Denpasar, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3004329628
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 2 compliance actions under PT. Intimas Surya: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 23, 2011.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004329628Denpasar, Indonesia2Sep 14, 2017
FEI 3004254617Jakarta, Indonesia2Jul 27, 2017

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