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PT Mayora Indah Tbk

FDA Regulatory Profile

PT Mayora Indah Tbk has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "PT Mayora Indah Tbk".

Latest inspection
Jun 29, 2023 · VAI

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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
Inspections5Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

PT Mayora Indah Tbk's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

PT Mayora Indah Tbk: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
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202000000
201910000
201800000
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Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

5 inspections from Aug 14, 2015 to Jun 29, 2023.

DateSiteProductClassificationFEI
Jun 29, 2023Tangerang, IndonesiaFood/CosmeticsVoluntary Action Indicated (VAI)3013309133
Oct 21, 2019Cibitung Bekasi, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3011378987
Aug 24, 2015Tangerang, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3011378490
Aug 21, 2015Tangerang, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3013309133
Aug 14, 2015Cibitung Bekasi, IndonesiaFood/CosmeticsNo Action Indicated (NAI)3011378987
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013309133Tangerang, Indonesia2Jun 29, 2023
FEI 3011378987Cibitung Bekasi, Indonesia2Oct 21, 2019
FEI 3011378490Tangerang, Indonesia1Aug 24, 2015

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FDA data resources

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