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Wooshin Labottach Co.,Ltd.

FDA import alert and refusal historySeoul, South KoreaFEI 3016548767

Recorded by FDA as WOOSHIN LABOTTACH CO.,LTD.

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Example subjectWooshin Labottach Co.,Ltd added to Import Alert 16-129 (red list)

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As of October 26, 2026, Wooshin Labottach Co.,Ltd. (Seoul, South Korea) is on the red list of FDA Import Alert 99-39 (Imported foods that appear to be misbranded) for gut support with probiotics; nerve + neuropathy support; weight control, published by FDA on October 12, 2023, and has 3 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Last import refusal
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · INCONSPICU
Last warning letter
None found
Last inspection
None on record

Every FDA record for Wooshin Labottach Co.,Ltd.

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

2024

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.INCONSPICULACKS FIRMNCONTACTNUTRIT LBLEntry EP8-2596043-8Show 2 lines
    Source
  2. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.INCONSPICULACKS FIRMNUTRIT LBLUNAPPROVEDEntry EP8-2596043-8
    Source

2023

  1. Import alert listing
    Listed on Import Alert 99-39red listGut Support with Probiotics; Nerve + Neuropathy Support; Weight Control
    Source

Refusal charges, in plain English

  • INCONSPICU3 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.

  • LACKS FIRM3 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.

  • NUTRIT LBL3 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.

  • NCONTACT2 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.

  • UNAPPROVED2 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.

  • DIRSEXMPT1 refused line

    DIRSEXMPT

Questions about Wooshin Labottach Co.,Ltd.

Is Wooshin Labottach Co.,Ltd. on an FDA import alert?
Yes. As of October 26, 2026, Wooshin Labottach Co.,Ltd. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for gut support with probiotics; nerve + neuropathy support; weight control; FDA published the listing on October 12, 2023.
Has FDA refused shipments from Wooshin Labottach Co.,Ltd.?
Yes. FDA refused 3 shipment lines from Wooshin Labottach Co.,Ltd. between February 15, 2024 and March 6, 2024. The most recent, on March 6, 2024, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as INCONSPICU (required information not conspicuous).
Why did FDA refuse Wooshin Labottach Co.,Ltd.'s shipments?
The most frequent charges are INCONSPICU (required information not conspicuous, 3 lines) and LACKS FIRM (manufacturer name and address missing, 3 lines).
What is Wooshin Labottach Co.,Ltd.'s FEI number?
Wooshin Labottach Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3016548767.
Can shipments from Wooshin Labottach Co.,Ltd. still enter the U.S.?
Shipments of gut support with probiotics; nerve + neuropathy support; weight control from Wooshin Labottach 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).

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Example subjectWooshin Labottach Co.,Ltd added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.