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FDA Inspections, Warning Letters and Import Refusals: Japan

FDA has recorded 1,925 inspections of firms in Japan, 104 of them (5.4%) classified OAI. It has issued 74 warning letters to firms there and refused 11,366 import shipments. 329 firms in Japan 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.

Japan: FDA inspections per year 2017: 147 inspections14720172018: 170 inspections17020182019: 114 inspections11420192020: 9 inspections920202021: 3 inspections320212022: 35 inspections3520222023: 149 inspections14920232024: 119 inspections11920242025: 121 inspections12120252026: 122 inspections1222026
YearInspectionsOAIOAI shareWarning lettersImport refusals
202612221.6%2193
2025121129.9%0363
202411932.5%4335
202314953.4%6370
202235617.1%2324
20213133.3%1265
20209111.1%1460
201911487.0%3659
201817021.2%7382
201714785.4%3442

Latest OAI inspections

DateFacilityProduct type
Jul 22, 2026NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORYFood/Cosmetics
Jun 12, 2026Nikken Medical CorporationFood/Cosmetics
Nov 21, 2025Olympus Medical Systems CorporationDevices
Nov 21, 2025Sato Pharmaceutical Co., Ltd.Drugs
Nov 21, 2025OLYMPUS MEDICAL SYSTEMS CORP. Hinode PlantDevices
Sep 22, 2025Orthorebirth Co LtdDevices
Sep 3, 2025Oak K.K., CorporationFood/Cosmetics
Sep 1, 2025KOKUYO CO.,LTD.Food/Cosmetics
Jul 1, 2025Shionogi Pharma Co., Ltd.Drugs
Apr 17, 2025Sunsho Pharmaceutical Co., Ltd.Food/Cosmetics
Feb 28, 2025TAIYO TSUKEMONO CORPORATIONFood/Cosmetics
Feb 21, 2025ICHIEI FOODS CO., LTD.Food/Cosmetics
Feb 7, 2025Kaneko Sangyo Co., Ltd.Food/Cosmetics
Jan 30, 2025Riken Keiki Co., Ltd.Devices
Nov 13, 2024HICHIFUKU JYOZO CO.,LTD.Food/Cosmetics
May 27, 2024Miyajima Shoyu Co., Ltd.Food/Cosmetics
May 17, 2024FCC Horiuchi Co., Ltd.Food/Cosmetics
Jun 9, 2023Shima Laboratories Co., Ltd.Devices
May 19, 2023Neitz Instruments Co., Ltd.Devices
May 18, 2023Unisis Corp.Devices
Feb 9, 2023Fukusui Shoji Ltd.Food/Cosmetics
Jan 26, 2023Marumo Co., Ltd.Food/Cosmetics
Nov 10, 2022OLYMPUS MEDICAL SYSTEMS CORP. Hinode PlantDevices
Sep 14, 2022Marukyo Co., Ltd.Food/Cosmetics
Sep 9, 2022Olympus Medical Systems CorporationDevices

Showing the latest 25 of 104.

Latest warning letters

DateFirmProduct typeFDA center
Jun 2, 2026Asanuma Corporation - Sagamihara FactoryDrugsCDER
May 19, 2026Sato Pharmaceutical Co., Ltd.DrugsCDER
Oct 17, 2024Maruhachi Muramatsu Inc., Danchi FactoryFood/CosmeticsCFSAN
Oct 1, 2024Miyajima Shoyu Co., Ltd.Food/CosmeticsCFSAN
Sep 12, 2024Mery VapeTobaccoCTP
May 6, 2024Ogura Shokuhin Co LtdFood/CosmeticsCFSAN
Oct 2, 2023Neitz Instruments Co., Ltd.DevicesCDRH
Jul 5, 2023Marumo Co., Ltd.Food/CosmeticsCFSAN
Jun 27, 2023Fukusui Shoji Ltd.Food/CosmeticsCFSAN
Mar 15, 2023OLYMPUS MEDICAL SYSTEMS CORP. Hinode PlantDevicesCDRH
Feb 7, 2023NARA CO.,LTD.Food/CosmeticsCFSAN
Jan 1, 2023Hoya Corporation - Pentax Life DivisionDevicesCDRH
Dec 12, 2022Olympus Medical Systems CorporationDevicesCDRH
Nov 2, 2022Aizu Olympus Co., Ltd.DevicesCDRH
Aug 19, 2021Toyobo Co. Ltd.DrugsCDER
Jun 10, 2020Takeda Pharmaceutical Company LimitedDrugsCDER
Sep 18, 2019KAKUSHIME MATSUDA SUISANFood/CosmeticsCFSAN
May 8, 2019TSUKIJI MOTOHIKO CO., LTD.Food/CosmeticsCFSAN
Mar 14, 2019Marukyo Co., Ltd.Food/CosmeticsCFSAN
Aug 10, 2018Kyowa Hakko Bio Co., Ltd.DrugsCDER
Jul 17, 2018Yuki Gosei Kogyo Co., Ltd.DrugsCDER
Mar 29, 2018Jam VapesTobaccoCTP
Mar 9, 2018Fujifilm CorporationDevicesCDRH
Mar 9, 2018Hoya Corporation - Pentax Life DivisionDevicesCDRH
Mar 9, 2018Olympus Medical Systems CorporationDevicesCDRH

Showing the latest 25 of 74.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026Japan Bio Products Co.,LtdDevices
Oct 22, 2026Oak K.K., CorporationHuman Foods
Oct 21, 2026API CO LTDHuman Foods
Oct 21, 2026AKITA SHOKUSAN, CO., LTDHuman Foods
Oct 21, 2026AKITA SHOKUSAN, CO., LTDHuman Foods
Oct 20, 2026Hotei Foods CorporationHuman Foods
Oct 20, 2026Hotei Foods CorporationHuman Foods
Oct 19, 2026KOMATSU SUISAN CO., LTD.Human Foods
Oct 15, 2026EXPANDY CO LTDHuman Foods
Oct 14, 2026Club Cosmetic Kk.Drugs and Biologics
Oct 14, 2026NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORYHuman Foods
Oct 9, 2026Melsmon Pharmaceutical Co., Ltd.Drugs and Biologics
Oct 9, 2026Rohto Pharmaceutical Co., Ltd.Cosmetics
Oct 7, 2026AIZIN INC.Drugs and Biologics
Oct 6, 2026EYE FACTORY CO., LTDHuman Foods
Oct 6, 2026MORINAGA CO LTDHuman Foods
Oct 2, 2026Club Cosmetic Kk.Cosmetics
Oct 2, 2026Club Cosmetic Kk.Cosmetics
Oct 2, 2026Club Cosmetic Kk.Drugs and Biologics
Oct 2, 2026AKITA SHOKUSAN, CO., LTDHuman Foods
Oct 2, 2026AKITA SHOKUSAN, CO., LTDHuman Foods
Sep 30, 2026Oak K.K., CorporationHuman Foods
Sep 30, 2026Oak K.K., CorporationHuman Foods
Sep 29, 2026Sunsho Pharmaceutical Co., Ltd.Human Foods
Sep 28, 2026Seirin CorporationDevices

Showing the latest 25 of 11,366.

See every import refusal from Japan.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 6, 2026Sakura Shokuhin Co., Ltd.16-120red
Oct 19, 2026AOMORI OLYMPUS CO., LTD. Kuroishi Site89-04red
Oct 19, 2026OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant89-04red
Oct 19, 2026Shirakawa Olympus Co., Ltd.89-04red
Sep 30, 2026EHIME FISHERIES COOPERATIVE16-125green
Sep 30, 2026KOMATSU SUISAN CO., LTD.16-39red
Sep 21, 2026Nikken Medical Corporation54-14red
Sep 9, 2026NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORY16-120red
Aug 26, 2026Powerful Health Food Co., Ltd.54-14red
Aug 17, 2026KOKUYO CO.,LTD.99-37red
Aug 13, 2026Global Vision, Inc.66-41red
Jul 28, 2026Oak K.K., Corporation16-120red
Jun 23, 2026Kobayashi Pharmaceutical Co Ltd66-41red
Jun 5, 2026Fuji Shokuhin Co., Ltd.99-37red
May 29, 2026Japan Bio Products Co.,Ltd57-22red
May 29, 2026JAPAN BIO PRODUCTS CO LTD57-22red
May 29, 2026JAPAN BIO PRODUCTS CO., LTD.57-22red
Apr 6, 2026ACE BAKERY.Co., Ltd33-15red
Jan 9, 2026Asanuma Corporation - Sagamihara Factory66-40red
Nov 21, 2025SASAKI FOOD16-04red
Nov 21, 2025SASAKI FOODS CO.,LTD16-04red
Oct 15, 2025ICHIEI FOODS CO., LTD.99-37red
Aug 6, 2025Sunsho Pharmaceutical Co., Ltd.54-14red
Aug 6, 2025Sunsho Pharmaceutical Co., Ltd.54-14red
Jul 17, 2025MITSUI FISHERIES CO LTD16-125green

Showing the latest 25 of 329.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Takeda Pharmaceutical Company LimitedHikari91Nov 6, 2023
Department Of Defense - Air Force 35Th Medical GroupMisawa80Sep 25, 2026
Department Of Defense - Air Force 374Th Medical GroupApo80Sep 22, 2026
Alps Pharmaceutical Industrial Co., Ltd.Hida80Oct 17, 2025
Tomita Pharmaceutical Co., Ltd.Naruto80May 23, 2025
Department Of Defense-Navy; US Naval Hospital YokosukaYokosuka70Sep 18, 2026
Yuki Gosei Kogyo Co., Ltd.Iwaki72Feb 6, 2026
Sucampo Pharma, LLCSanda70Nov 7, 2025
Sumitomo Chemical Co., Ltd.Anpachi-Gun71Oct 31, 2025
Shionogi Pharma Co., Ltd.Isawa-Gun71Jul 1, 2025
Kyowa Hakko Bio Co., Ltd.Hofu74Sep 20, 2024
Takeda Pharmaceutical Company LimitedYodogawa-Ku70Apr 12, 2024
Chugai Pharma Manufacturing Co. Ltd.Utsunomiya70Apr 2, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.Tokushima70Mar 22, 2024
Eisai Co., Ltd.Kamisu60Jul 24, 2026

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.