FCC Horiuchi Co., Ltd.

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

Refusal charges, in plain English

• INCONSPICU1 refused line

  Required information not conspicuous

  Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

• JUICE %1 refused line

  Juice percentage not declared

  The product is presented as a beverage containing fruit or vegetable juice and the label appeared not to state the total percentage of juice on the information panel.

• LACKS N/C1 refused line

  Net quantity statement missing

  The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

• LIST INGRE1 refused line

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• 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.

• NO ENGLISH1 refused line

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• 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.

• SUPPL GMP1 refused line

  Dietary supplement CGMP not met

  The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.

Questions about FCC Horiuchi Co., Ltd.

Is FCC Horiuchi Co., Ltd. on an FDA import alert?

Yes. As of October 26, 2026, FCC Horiuchi Co., Ltd. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for pure sea fucoidan product; FDA published the listing on November 20, 2024.

Has FDA refused shipments from FCC Horiuchi Co., Ltd.?

Yes. FDA refused 3 shipment lines from FCC Horiuchi Co., Ltd. between August 18, 2017 and December 31, 2024. The most recent, on December 31, 2024, was foods with supplemental nutrients added, with or without artifical sweetners, charged as SUPPL GMP (dietary supplement cgmp not met).

Why did FDA refuse FCC Horiuchi Co., Ltd.'s shipments?

The most frequent charges are INCONSPICU (required information not conspicuous, 1 line) and JUICE % (juice percentage not declared, 1 line).

When was FCC Horiuchi Co., Ltd. last inspected by FDA?

FDA's most recent inspection of FCC Horiuchi Co., Ltd. with a final classification is dated May 17, 2024 and was classified OAI (Official Action Indicated).

What is FCC Horiuchi Co., Ltd.'s FEI number?

FCC Horiuchi Co., Ltd.'s FDA Establishment Identifier (FEI) is 3012144040.

Can shipments from FCC Horiuchi Co., Ltd. still enter the U.S.?

Shipments of pure sea fucoidan product from FCC Horiuchi Co., Ltd. can be detained without physical examination under Import Alert 99-39; 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).