Tsukezen Shoten Co.,Ltd.
FDA import alert and refusal historyKobe, JapanFEI 3004257469
Recorded by FDA as TSUKEZEN SHOTEN CO.,LTD.
As of October 26, 2026, Tsukezen Shoten Co.,Ltd. (Kobe, 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 1 FDA import refusal 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
- Sauces, n.e.c. · NO PROCESS
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Tsukezen Shoten Co.,Ltd.
2 records, newest first. Each line links to the FDA page it came from.
2019
- Import refusalRefused, Sauces, n.e.c.NO PROCESSEntry HE8-0182414-6Source
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 PROCESS1 refused line
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.
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 1 shipment line from Tsukezen Shoten Co.,Ltd. on August 8, 2019. The most recent, on August 8, 2019, was sauces, n.e.c., charged as NO PROCESS (no scheduled process filed).
- Why did FDA refuse Tsukezen Shoten Co.,Ltd.'s shipments?
- The most frequent charge is NO PROCESS (no scheduled process filed, 1 line).
- What is Tsukezen Shoten Co.,Ltd.'s FEI number?
- Tsukezen Shoten Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3004257469.
- 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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