PT. Tuna Permata Rezeki FDA Record

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

  • Latest inspection NAI · Aug 27, 2015
  • Last warning letter 2011
Inspections 3 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Mar 9, 2011
510(k) clearances 0 None on file

PT. Tuna Permata Rezeki has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to PT. Tuna Permata Rezeki, the most recent on Mar 9, 2011.

What these totals cover: FDA records filed under the name "PT. Tuna Permata Rezeki".

Latest inspection
Aug 27, 2015 · 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
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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PT. Tuna Permata Rezeki FDA Warning Letters

1 warning letter on Mar 9, 2011.

IssuedSubjectIssuing officeClose-out letter
Mar 9, 2011 · 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

3 inspections from Oct 22, 2010 to Aug 27, 2015.

DateSiteProductClassificationFEI
Aug 27, 2015Jakarta, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3004138684
Feb 21, 2012Jakarta, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3004138684
Oct 22, 2010Jakarta, IndonesiaFood/CosmeticsOfficial Action Indicated (OAI)3004138684
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 PT. Tuna Permata Rezeki: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 9, 2011.

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 3004138684Jakarta, Indonesia3Aug 27, 2015

PT. Tuna Permata Rezeki and the FDA: common questions

Has PT. Tuna Permata Rezeki received an FDA warning letter?

Yes. FDA has issued 1 warning letter to PT. Tuna Permata Rezeki. The most recent is dated Mar 9, 2011.

Has PT. Tuna Permata Rezeki received an FDA Form 483?

FDA has not published a Form 483 for "PT. Tuna Permata Rezeki" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PT. Tuna Permata Rezeki?

The most recent FDA inspection on file ended Aug 27, 2015 at Jakarta, Indonesia and was classified NAI. FDA has 3 inspections of PT. Tuna Permata Rezeki 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.