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FDA Inspections, Warning Letters and Import Refusals: Indonesia

FDA has recorded 439 inspections of firms in Indonesia, 20 of them (4.6%) classified OAI. It has issued 55 warning letters to firms there and refused 9,135 import shipments. 367 firms in Indonesia are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

All countries · Check one supplier with the free FDA compliance check.

By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

Indonesia: FDA inspections per year 2017: 39 inspections3920172018: 66 inspections6620182019: 41 inspections4120192020: 9 inspections920202021: 0 inspections020212022: 12 inspections1220222023: 31 inspections3120232024: 34 inspections3420242025: 9 inspections920252026: 1 inspections12026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026100.0%0342
2025900.0%0625
20243412.9%1158
20233126.5%2199
20221200.0%1283
2021000414
2020900.0%1301
20194124.9%2464
20186600.0%6420
20173900.0%3233

Latest OAI inspections

DateFacilityProduct type
Dec 5, 2024PT. Anugrah Laut IndonesiaFood/Cosmetics
Aug 23, 2023Pt Dua KelinciFood/Cosmetics
May 11, 2023P.T. Sankei Medical IndustriesDevices
Nov 15, 2019PT. MegaSurya MasDrugs
Jan 22, 2019PT. Primo Indo IkanFood/Cosmetics
Sep 1, 2015PERUSAHAAN KERUPUK KOMODOFood/Cosmetics
Aug 25, 2015PT. Marizarasa SarimurniFood/Cosmetics
Aug 19, 2015Pt. Mikie Oleo Nabati IndustriFood/Cosmetics
Aug 19, 2015PT. Muria Bahari IndonesiaFood/Cosmetics
May 1, 2012Old Medan BMSfoodFood/Cosmetics
Mar 30, 2012PT. Super Saku BaliFood/Cosmetics
Mar 14, 2012PT Toba Surimi IndustriesFood/Cosmetics
Feb 17, 2012Pt. Berkat Rasa FajarindoFood/Cosmetics
Jun 9, 2011PT. Nutrindo Fresfood InternasionalFood/Cosmetics
Jun 4, 2011Pt. Bitung Mina UtamaFood/Cosmetics
May 25, 2011PT. Intimas SuryaFood/Cosmetics
May 18, 2011P.T. BonecomFood/Cosmetics
Oct 22, 2010PT. Tuna Permata RezekiFood/Cosmetics
Oct 19, 2010Pt. Indomaguro Tunas UnggulFood/Cosmetics
Oct 13, 2010P. T. Lautan Bahari SejahteraFood/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Feb 9, 2024Pt Dua KelinciFood/CosmeticsCFSAN
Sep 19, 2023P.T. Sankei Medical IndustriesDevicesCDRH
Sep 5, 2023PT. Winson Prima SejahteraFood/CosmeticsCFSAN
Apr 8, 2022CheapCigStore.ComTobaccoCTP
Aug 24, 2020PT. MegaSurya MasDrugsCDER
Oct 28, 2019PT. SIG ASIAFood/CosmeticsCFSAN
May 30, 2019PT. Primo Indo IkanFood/CosmeticsCFSAN
Jan 9, 2018PT Anugerah Lestari AbadiFood/CosmeticsCFSAN
Jan 9, 2018Pt Mitra T.N.Food/CosmeticsCFSAN
Jan 9, 2018PT Sekar Subur AbadiFood/CosmeticsCFSAN
Jan 9, 2018PT Shimasse Prata CitraFood/CosmeticsCFSAN
Jan 9, 2018Pt.Sukse SejatiFood/CosmeticsCFSAN
Jan 9, 2018Tritos SejahteraFood/CosmeticsCFSAN
Dec 29, 2017PT. GALAXY NUSA DUAFood/CosmeticsCFSAN
Dec 29, 2017PT. Nusantara Jaya AbadiFood/CosmeticsCFSAN
Dec 29, 2017Transbuana International ExpressFood/CosmeticsCFSAN
Aug 4, 2016Http://Cigaretkretek.ComTobaccoCTP
Jul 26, 2016PT Tritunggal Lintas BenuaFood/CosmeticsCFSAN
Mar 30, 2016Www.Smokerlink.ComTobaccoCTP
Feb 18, 2016Original Cigarettes IndonesiaTobaccoCTP
Jan 27, 2016CV Arira PangindoFood/CosmeticsCFSAN
Jan 27, 2016PT. United Kretek IndonesiaTobaccoCTP
Nov 18, 2015Yuga MochtarTobaccoCTP
Nov 5, 2015Djarum America International Co., Ltd.TobaccoCTP
Jun 30, 2015Www.Beclassifieds.ComTobaccoCTP

Showing the latest 25 of 55.

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 21, 2026DOSH POUCHES PTTobacco Products
Oct 21, 2026DOSH POUCHES PTTobacco Products
Oct 21, 2026DOSH POUCHES PTTobacco Products
Oct 16, 2026PT. Tridaya Jaya ManunggalHuman Foods
Oct 16, 2026PT. Tridaya Jaya ManunggalHuman Foods
Oct 16, 2026PT. Tridaya Jaya ManunggalHuman Foods
Oct 16, 2026PT. Tridaya Jaya ManunggalHuman Foods
Oct 13, 2026PT.Indoharvest SpiceHuman Foods
Oct 12, 2026PT RAJA IMPEXCosmetics
Oct 1, 2026PT. WINAROS KAWULA BAHARIHuman Foods
Oct 1, 2026PT. WINAROS KAWULA BAHARIHuman Foods
Oct 1, 2026PT. WINAROS KAWULA BAHARIHuman Foods
Oct 1, 2026PT. WINAROS KAWULA BAHARIHuman Foods
Oct 1, 2026CV Anugerah UtamaHuman Foods
Sep 29, 2026Haldin Pacific Semesta (Cikarang)Human Foods
Sep 29, 2026PT. NESTLE INDONESIAHuman Foods
Sep 29, 2026PT. Sumindo Karya AbadiHuman Foods
Sep 29, 2026DOSH POUCHESTobacco Products
Sep 29, 2026DOSH POUCHESTobacco Products
Sep 25, 2026PT. Dharma Samudera Fishing Industries, TbkHuman Foods
Sep 25, 2026PT. Dharma Samudera Fishing Industries, TbkHuman Foods
Sep 25, 2026PT. Dharma Samudera Fishing Industries, TbkHuman Foods
Sep 25, 2026DOSH POUCHESTobacco Products
Sep 24, 2026PT. Dharma Samudera Fishing Industries, TbkHuman Foods
Sep 24, 2026PT. Dharma Samudera Fishing Industries, TbkHuman Foods

Showing the latest 25 of 9,135.

See every import refusal from Indonesia.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 13, 2026PT. WINAROS KAWULA BAHARI16-127red
Oct 9, 2026CV Anugerah Utama99-19red
Oct 7, 2026CV Sumber Alam99-19red
Aug 19, 2026Pt. Sekar Bumi, Tbk.16-129red
Aug 17, 2026DOSH POUCHES PT98-06red
May 26, 2026PT. PABRIK LAMONGAN BMI99-39red
May 15, 2026PT. PABRIK LAMONGAN BMI99-47red
Apr 21, 2026PT. SUKSES LAUTAN INDONESIA16-81red
Apr 1, 2026PT Bandar Nelayan16-105red
Dec 23, 2025CABANG KIM PT. BAHARI MAKMUR SEJATI16-18green
Dec 18, 2025PT RECKITT BENCKISER TRADING INDONESIA66-41red
Dec 18, 2025Reckitt Benckiser Indonesia66-41red
Oct 3, 2025PT. Bahari Makmur Sejati99-52red
Oct 3, 2025PT Natural Java Spice99-52red
Sep 18, 2025PT Natural Java Spice99-51red
Aug 14, 2025PT. Bahari Makmur Sejati99-51red
Jul 23, 2025MARINA SEJAHTERA16-81red
Jun 4, 2025P. T Risly99-45red
May 23, 2025PT. Anugrah Laut Indonesia16-120red
May 13, 2025PT Sinar Sosro Pabrik Tambun99-45red
May 1, 2025PT Sinar Sosro Pabrik Tambun99-39red
Apr 30, 2025CV. SEMESTA HASIL LAUT16-81red
Apr 10, 2025AUDIMA CO., LTD16-81red
Apr 10, 2025PT. Halimas Mina Utama16-81red
Apr 10, 2025PT Indaco Anekajaya16-81red

Showing the latest 25 of 367.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Pt. Kelola Mina Laut- Integrated Seafood IndustriesGresik40Jun 23, 2023
Pt Ciba Vision BatamBatam Island40Aug 26, 2022
PT. Sari Tuna MakmurAertembaga Bitung30Mar 7, 2025
PT. Chen Woo FisheryMakassar30Mar 9, 2024
PT. Deho Canning CompanyBitung30Jan 16, 2023
Pt. Berkat Rasa FajarindoJakarta Utara31Nov 10, 2022
PT. Primo Indo IkanDenpasar31Jan 22, 2019
PT. Nutrindo Fresfood InternasionalBitung31Jan 9, 2019
UD. DamenaDenpasar30Jan 13, 2018
PT Toba Surimi IndustriesDeli Serdang31Jan 5, 2018
PT Phillips Seafoods Indonesia, Lampung PlantBandar Lampung30Jul 18, 2017
PT. Super Saku BaliDenpasar31May 13, 2016
PT. Tuna Permata RezekiJakarta31Aug 27, 2015
P.T. Nipro Indonesia JayaKarawang20Sep 3, 2026
PT. TEAM-METAL INDONESIABatam20Dec 4, 2024

See each facility's Form 483 observations with the FDA 483 search.

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