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Polski Lek S.A.

FDA import alert and refusal historyWadowice, PolandFEI 3008924214

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Example subjectPolski Lek S.A added to Import Alert 16-129 (red list)

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As of October 26, 2026, Polski Lek S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines between October 2, 2020 and July 25, 2022, most often for required label information not in english (NO ENGLISH).

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

Current status

Import alerts
Not listed
Last import refusal
Herbals & botanicals (not teas), n.e.c. · NO ENGLISH
Last warning letter
None found
Last inspection
None on record

Every FDA record for Polski Lek S.A.

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

2022

  1. Import refusal
    Refused, Herbals & botanicals (not teas), n.e.c.NO ENGLISHNUTRIT LBLEntry 274-0278027-7
    Source
  2. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHEntry 799-6947401-3
    Source
  3. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHEntry 799-6309859-4
    Source

2020

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.LIST INGREDIETARYINGNCONTACTLABELINGNUTRIT LBLEntry 799-8854681-6
    Source

Refusal charges, in plain English

  • NO ENGLISH3 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.

  • NUTRIT LBL2 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.

  • DIETARYING1 refused line

    Dietary ingredients not listed

    The dietary supplement label appeared not to list each dietary ingredient and its quantity, or the total quantity of a proprietary blend.

  • LABELING1 refused line

    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.

  • 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).

  • NCONTACT1 refused line

    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.

Questions about Polski Lek S.A.

Is Polski Lek S.A. on an FDA import alert?
No listing for Polski Lek S.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Poland page.
Has FDA refused shipments from Polski Lek S.A.?
Yes. FDA refused 4 shipment lines from Polski Lek S.A. between October 2, 2020 and July 25, 2022. The most recent, on July 25, 2022, was herbals & botanicals (not teas), n.e.c., charged as NO ENGLISH (required label information not in english).
Why did FDA refuse Polski Lek S.A.'s shipments?
The most frequent charges are NO ENGLISH (required label information not in english, 3 lines) and NUTRIT LBL (nutrition information missing from label, 2 lines).
What is Polski Lek S.A.'s FEI number?
Polski Lek S.A.'s FDA Establishment Identifier (FEI) is 3008924214.

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Example subjectPolski Lek S.A 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.