PT. Indokom Samudra Persada FDA Record

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

PT. Indokom Samudra Persada has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PT. Indokom Samudra Persada" is on file.

What these totals cover: FDA records filed under the name "PT. Indokom Samudra Persada".

Latest inspection
Sep 13, 2019 · 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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Aug 11, 2015 to Sep 13, 2019.

DateSiteProductClassificationFEI
Sep 13, 2019Tanjung Bintang, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3004329720
Aug 11, 2015Tanjung Bintang, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3004329720
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 3004329720Tanjung Bintang, Indonesia2Sep 13, 2019

PT. Indokom Samudra Persada and the FDA: common questions

Has PT. Indokom Samudra Persada received an FDA warning letter?

No FDA warning letter addressed to the name "PT. Indokom Samudra Persada" 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 PT. Indokom Samudra Persada received an FDA Form 483?

FDA has not published a Form 483 for "PT. Indokom Samudra Persada" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PT. Indokom Samudra Persada?

The most recent FDA inspection on file ended Sep 13, 2019 at Tanjung Bintang, Indonesia and was classified NAI. FDA has 2 inspections of PT. Indokom Samudra Persada on file.

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