Tsukezen Shoten Co., Ltd.
FDA import alert and refusal historyOsaka, JapanFEI 1000335713
As of October 26, 2026, Tsukezen Shoten Co., Ltd. (Osaka, Japan) is on the red list of FDA Import Alert 99-37 (Low-acid canned/acidified foods without scheduled process) for whole grains/milled grain products/starches; bakery products/dough/mixes/icings; macaroni/noodle products; cereal preparations/breakfast foods; snack food items; milk/butter/dried milk products; cheese/cheese products; ice cream and related products; filled milk/imitation milk products; eggs/egg pr…, published by FDA on December 15, 2017, and has 3 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 99-37 · red list
- Last import refusal
- Plum, dried or paste · NO PROCESS
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Tsukezen Shoten Co., Ltd.
4 records, newest first. Each line links to the FDA page it came from.
2022
- Import refusalRefused, Plum, dried or pasteNO PROCESSEntry 750-0198757-9Source
2021
- Import refusalRefused, Millet seed (edible seed)NO PROCESSEntry 750-0195561-8Source
2018
- Import refusalRefused, Citron, citrus fruit juices or concentratesNEEDS FCENO PROCESSEntry 750-0180108-5Source
2017
- Import alert listingListed on Import Alert 99-37red listWhole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Preparations/Breakfast Foods; Snack Food Items; Milk/Butter/Dried Milk Products; Cheese/Cheese Products; Ice Cream and related Products; Filled Milk/Imitation Milk Products; Eggs/Egg Pr…Source
Refusal charges, in plain English
- NO PROCESS3 refused lines
No scheduled process filed
The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.
- NEEDS FCE1 refused line
Processor not registered for canned or acidified foods
The manufacturer appeared not to be registered with FDA as a low-acid canned food or acidified food processor, as 21 CFR 108.25 and 108.35 require.
Questions about Tsukezen Shoten Co., Ltd.
- Is Tsukezen Shoten Co., Ltd. on an FDA import alert?
- Yes. As of October 26, 2026, Tsukezen Shoten Co., Ltd. is on the red list of FDA Import Alert 99-37, “Low-acid canned/acidified foods without scheduled process”, for whole grains/milled grain products/starches; bakery products/dough/mixes/icings; macaroni/noodle products; cereal preparations/breakfast foods; snack food items; milk/butter/dried milk products; cheese/cheese products; ice cream and related products; filled milk/imitation milk products; eggs/egg pr…; FDA published the listing on December 15, 2017.
- Has FDA refused shipments from Tsukezen Shoten Co., Ltd.?
- Yes. FDA refused 3 shipment lines from Tsukezen Shoten Co., Ltd. between February 7, 2018 and July 15, 2022. The most recent, on July 15, 2022, was plum, dried or paste, charged as NO PROCESS (no scheduled process filed).
- Why did FDA refuse Tsukezen Shoten Co., Ltd.'s shipments?
- The most frequent charges are NO PROCESS (no scheduled process filed, 3 lines) and NEEDS FCE (processor not registered for canned or acidified foods, 1 line).
- What is Tsukezen Shoten Co., Ltd.'s FEI number?
- Tsukezen Shoten Co., Ltd.'s FDA Establishment Identifier (FEI) is 1000335713.
- Can shipments from Tsukezen Shoten Co., Ltd. still enter the U.S.?
- Shipments of whole grains/milled grain products/starches; bakery products/dough/mixes/icings; macaroni/noodle products; cereal preparations/breakfast foods; snack food items; milk/butter/dried milk products; cheese/cheese products; ice cream and related products; filled milk/imitation milk products; eggs/egg pr… from Tsukezen Shoten Co., Ltd. can be detained without physical examination under Import Alert 99-37; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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