Lotte Wellfood Co., Ltd. (Yangsan Factory)

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

Refusal charges, in plain English

• ALLERGEN29 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 INGRE15 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).

• NUTRIT LBL13 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.

• TRANSFAT6 refused lines

  TRANSFAT

• 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.

• ALRGN402A43 refused lines

  ALRGN402A4

• INCONSPICU2 refused lines

  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.

• LABELING2 refused lines

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

Questions about Lotte Wellfood Co., Ltd. (Yangsan Factory)

Is Lotte Wellfood Co., Ltd. (Yangsan Factory) on an FDA import alert?

Yes. As of October 26, 2026, Lotte Wellfood Co., Ltd. (Yangsan Factory) is on the red list of FDA Import Alert 99-22, “Undeclared or mislabeled major food allergens”, for cacao cake cookies; FDA published the listing on June 29, 2018.

Has FDA refused shipments from Lotte Wellfood Co., Ltd. (Yangsan Factory)?

Yes. FDA refused 31 shipment lines from Lotte Wellfood Co., Ltd. (Yangsan Factory) between March 19, 2019 and April 17, 2025. The most recent, on April 17, 2025, was chocolate filled/iced cookies,biscuits and wafers, charged as LIST INGRE (ingredients not listed).

Why did FDA refuse Lotte Wellfood Co., Ltd. (Yangsan Factory)'s shipments?

The most frequent charges are ALLERGEN (major food allergen not declared, 29 lines) and LIST INGRE (ingredients not listed, 15 lines).

When was Lotte Wellfood Co., Ltd. (Yangsan Factory) last inspected by FDA?

FDA's most recent inspection of Lotte Wellfood Co., Ltd. (Yangsan Factory) with a final classification is dated August 30, 2024 and was classified NAI (No Action Indicated).

What is Lotte Wellfood Co., Ltd. (Yangsan Factory)'s FEI number?

Lotte Wellfood Co., Ltd. (Yangsan Factory)'s FDA Establishment Identifier (FEI) is 3011370347.

Can shipments from Lotte Wellfood Co., Ltd. (Yangsan Factory) still enter the U.S.?

Shipments of cacao cake cookies from Lotte Wellfood Co., Ltd. (Yangsan Factory) can be detained without physical examination under Import Alert 99-22; 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).