KOLMAR BNH CO., LTD Eumseong Factory

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

Refusal charges, in plain English

• NUTRIT LBL8 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• ALLERGEN7 refused lines

  Major food allergen not declared

  The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.

• LIST INGRE7 refused lines

  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).

• DIETARYLBL5 refused lines

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• NCONTACT5 refused lines

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

• NO ENGLISH5 refused lines

  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.

• LACKS FIRM4 refused lines

  Manufacturer name and address missing

  The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

• UNAPPROVED4 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about KOLMAR BNH CO., LTD Eumseong Factory

Is KOLMAR BNH CO., LTD Eumseong Factory on an FDA import alert?

Yes. As of October 26, 2026, KOLMAR BNH CO., LTD Eumseong Factory is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for atomy probiotics dietary supplement; FDA published the listing on June 1, 2023.

Has FDA refused shipments from KOLMAR BNH CO., LTD Eumseong Factory?

Yes. FDA refused 17 shipment lines from KOLMAR BNH CO., LTD Eumseong Factory between August 8, 2018 and June 4, 2024. The most recent, on June 4, 2024, was milk thistle (herbal & botanical other than teas), charged as LIST INGRE (ingredients not listed).

Why did FDA refuse KOLMAR BNH CO., LTD Eumseong Factory's shipments?

The most frequent charges are NUTRIT LBL (nutrition information missing from label, 8 lines) and ALLERGEN (major food allergen not declared, 7 lines).

When was KOLMAR BNH CO., LTD Eumseong Factory last inspected by FDA?

FDA's most recent inspection of KOLMAR BNH CO., LTD Eumseong Factory with a final classification is dated July 25, 2024 and was classified NAI (No Action Indicated).

What is KOLMAR BNH CO., LTD Eumseong Factory's FEI number?

KOLMAR BNH CO., LTD Eumseong Factory's FDA Establishment Identifier (FEI) is 3011170371.

Can shipments from KOLMAR BNH CO., LTD Eumseong Factory still enter the U.S.?

Shipments of atomy probiotics dietary supplement from KOLMAR BNH CO., LTD Eumseong Factory 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).