PT. Bali Mina Utama FDA Record

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

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

What these totals cover: FDA records filed under the name "PT. Bali Mina Utama".

Latest inspection
Mar 27, 2012 · VAI

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 May 24, 2011 to Mar 27, 2012.

DateSiteProductClassificationFEI
Mar 27, 2012Denpasar, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3005887437
May 24, 2011Denpasar, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3005887437
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 3005887437Denpasar, Indonesia2Mar 27, 2012

PT. Bali Mina Utama and the FDA: common questions

Has PT. Bali Mina Utama received an FDA warning letter?

No FDA warning letter addressed to the name "PT. Bali Mina Utama" 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. Bali Mina Utama received an FDA Form 483?

FDA has not published a Form 483 for "PT. Bali Mina Utama" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PT. Bali Mina Utama?

The most recent FDA inspection on file ended Mar 27, 2012 at Denpasar, Indonesia and was classified VAI. FDA has 2 inspections of PT. Bali Mina Utama on file.

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