PT. Unimitra Andalan Sejati FDA Record

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

PT. Unimitra Andalan Sejati has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PT. Unimitra Andalan Sejati" is on file.

What these totals cover: FDA records filed under the name "PT. Unimitra Andalan Sejati".

Latest inspection
Jun 13, 2023 · 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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Jun 13, 2023.

DateSiteProductClassificationFEI
Jun 13, 2023Bekasi, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3017705684
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 3017705684Bekasi, Indonesia1Jun 13, 2023

PT. Unimitra Andalan Sejati and the FDA: common questions

Has PT. Unimitra Andalan Sejati received an FDA warning letter?

No FDA warning letter addressed to the name "PT. Unimitra Andalan Sejati" 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. Unimitra Andalan Sejati received an FDA Form 483?

FDA has not published a Form 483 for "PT. Unimitra Andalan Sejati" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect PT. Unimitra Andalan Sejati?

The most recent FDA inspection on file ended Jun 13, 2023 at Bekasi, Indonesia and was classified NAI. FDA has 1 inspection of PT. Unimitra Andalan Sejati on file.

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