Has FDA refused shipments from Tsukezen Shoten Co., Ltd. Kobe Ind.?

Yes. FDA refused 1 shipment line from Tsukezen Shoten Co., Ltd. Kobe Ind. on December 6, 2021. The most recent, on December 6, 2021, was ginger root (root & tuber vegetable), charged as NO PROCESS (no scheduled process filed).

Why did FDA refuse Tsukezen Shoten Co., Ltd. Kobe Ind.'s shipments?

The most frequent charge is NO PROCESS (no scheduled process filed, 1 line).

When was Tsukezen Shoten Co., Ltd. Kobe Ind. last inspected by FDA?

FDA's most recent inspection of Tsukezen Shoten Co., Ltd. Kobe Ind. with a final classification is dated September 5, 2017 and was classified OAI (Official Action Indicated).

What is Tsukezen Shoten Co., Ltd. Kobe Ind.'s FEI number?

Tsukezen Shoten Co., Ltd. Kobe Ind.'s FDA Establishment Identifier (FEI) is 3010014230.

Tsukezen Shoten Co., Ltd. Kobe Ind.

FDA import alert and refusal historyKobe, JapanFEI 3010014230

Recorded by FDA as TSUKEZEN SHOTEN CO., LTD. KOBE IND.

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As of October 26, 2026, Tsukezen Shoten Co., Ltd. Kobe Ind. (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 October 26, 2026. Request a correction

Current status

Import alerts: IA 99-37 · red list
Last import refusal: Dec 6, 2021Ginger root (root & tuber vegetable) · NO PROCESS
Last warning letter: None found
Last inspection: Sep 5, 2017Classified OAI (Official Action Indicated)

Every FDA record for Tsukezen Shoten Co., Ltd. Kobe Ind.

4 records, newest first. Each line links to the FDA page it came from.

2021

Dec 6, 2021Import refusal
Refused, Ginger root (root & tuber vegetable)NO PROCESSEntry 9XL-0107460-1
Source

2017

Dec 15, 2017Import alert listing
Listed 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
Sep 5, 2017Inspection
Inspection classified OAI (Official Action Indicated)Foodborne Biological Hazards
Source

2014

Jul 23, 2014Inspection
Inspection classified OAI (Official Action Indicated)Foodborne Biological Hazards
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. Kobe Ind.

Is Tsukezen Shoten Co., Ltd. Kobe Ind. on an FDA import alert?: Yes. As of October 26, 2026, Tsukezen Shoten Co., Ltd. Kobe Ind. 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. Kobe Ind.?: Yes. FDA refused 1 shipment line from Tsukezen Shoten Co., Ltd. Kobe Ind. on December 6, 2021. The most recent, on December 6, 2021, was ginger root (root & tuber vegetable), charged as NO PROCESS (no scheduled process filed).
Why did FDA refuse Tsukezen Shoten Co., Ltd. Kobe Ind.'s shipments?: The most frequent charge is NO PROCESS (no scheduled process filed, 1 line).
When was Tsukezen Shoten Co., Ltd. Kobe Ind. last inspected by FDA?: FDA's most recent inspection of Tsukezen Shoten Co., Ltd. Kobe Ind. with a final classification is dated September 5, 2017 and was classified OAI (Official Action Indicated).
What is Tsukezen Shoten Co., Ltd. Kobe Ind.'s FEI number?: Tsukezen Shoten Co., Ltd. Kobe Ind.'s FDA Establishment Identifier (FEI) is 3010014230.
Can shipments from Tsukezen Shoten Co., Ltd. Kobe Ind. 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. Kobe Ind. 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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