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PT. Winson Prima Sejahtera

FDA import alert and refusal historyMedan, IndonesiaFEI 3012379444

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Example subjectPT. Winson Prima Sejahter added to Import Alert 16-129 (red list)

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As of October 26, 2026, PT. Winson Prima Sejahtera (Medan, Indonesia) is on the red list of FDA Import Alert 16-120 (Seafood from processors not in compliance with HACCP) for tuna, published by FDA on January 23, 2024, is also listed on Import Alert 16-105 (red list), and has 37 FDA import refusals recorded since October 2016.

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

Current status

Import alerts
IA 16-120 · red listIA 16-105 · red list
Last import refusal
Tuna (albacore, yellowfin, bluefin, skipjack, etc.) · FILTHY
Last warning letter
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Last inspection
Classified VAI (Voluntary Action Indicated)

Every FDA record for PT. Winson Prima Sejahtera

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

2024

  1. Import alert listing
    Listed on Import Alert 16-120red listTuna
    Source

2023

  1. Warning letter
    Warning letter issuedSeafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
    Source

2022

  1. Import refusal
    Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1772912-0Show 3 lines
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1772912-0Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1772912-0Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1772912-0Source
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEFILTHYEntry D97-1758240-4Show 2 lines
    Source
  3. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEFILTHYEntry D97-1745208-7
    Source
  4. Import refusal
    Refused, 2 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry D97-1725282-6Show 2 lines
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry D97-1725282-6Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry D97-1725282-6Source
    Source
  5. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6042468-8
    Source

2021

  1. Import refusal
    Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEFILTHYEntry TZ6-6039710-8Show 3 lines
    Source
  2. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYPOISONORDEntry D97-1663051-9
    Source
  3. Import refusal
    Refused, 6 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYPOISONORDEntry D97-1663051-9Show 6 lines
    Source
  4. Import refusal
    Refused, 4 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6034073-6Show 4 lines
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6034073-6Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6034073-6Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6034073-6Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry TZ6-6034073-6Source
    Source
  5. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYPOISONORDEntry D97-1663051-9
    Source
  6. Import refusal
    Refused, 4 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEFILTHYEntry TZ6-6039163-0Show 4 lines
    Source
  7. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEEntry D97-1327368-5
    Source
  8. Import refusal
    Refused, 8 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Show 8 lines
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry D97-1456704-4Source
    Source
Show 2 earlier records (2018–2021)

2021

  1. Import alert listing
    Listed on Import Alert 16-105red listTuna
    Source

2018

  1. Inspection
    Inspection classified VAI (Voluntary Action Indicated)Foodborne Biological Hazards
    Source

Refusal charges, in plain English

  • FILTHY29 refused lines

    Filthy, putrid or decomposed substance

    The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

  • HISTAMINE18 refused lines

    Histamine

    The product appeared to contain histamine in a quantity that ordinarily makes it injurious to health.

  • POISONORD8 refused lines

    Poisonous or deleterious substance (ordinarily injurious)

    The product appeared to contain a poisonous or deleterious substance in a form or amount that would ordinarily render it injurious to health.

Questions about PT. Winson Prima Sejahtera

Is PT. Winson Prima Sejahtera on an FDA import alert?
Yes. As of October 26, 2026, PT. Winson Prima Sejahtera is on the red list of FDA Import Alert 16-120, “Seafood from processors not in compliance with HACCP”, for tuna; FDA published the listing on January 23, 2024.
Has FDA refused shipments from PT. Winson Prima Sejahtera?
Yes. FDA refused 37 shipment lines from PT. Winson Prima Sejahtera between August 16, 2021 and November 21, 2022. The most recent, on November 21, 2022, was tuna (albacore, yellowfin, bluefin, skipjack, etc.), charged as FILTHY (filthy, putrid or decomposed substance).
Why did FDA refuse PT. Winson Prima Sejahtera's shipments?
The most frequent charges are FILTHY (filthy, putrid or decomposed substance, 29 lines) and HISTAMINE (histamine, 18 lines).
Has PT. Winson Prima Sejahtera received an FDA warning letter?
Yes. FDA issued a warning letter to PT. Winson Prima Sejahtera on September 5, 2023 (Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions).
When was PT. Winson Prima Sejahtera last inspected by FDA?
FDA's most recent inspection of PT. Winson Prima Sejahtera with a final classification is dated September 12, 2018 and was classified VAI (Voluntary Action Indicated).
What is PT. Winson Prima Sejahtera's FEI number?
PT. Winson Prima Sejahtera's FDA Establishment Identifier (FEI) is 3012379444.
Can shipments from PT. Winson Prima Sejahtera still enter the U.S.?
Shipments of tuna from PT. Winson Prima Sejahtera can be detained without physical examination under Import Alert 16-120; 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 subjectPT. Winson Prima Sejahter 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.