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PT Fanwell Wira Mandiri

FDA import alert and refusal historyJakarta, IndonesiaFEI 3014162861

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Example subjectPT Fanwell Wira Mandir added to Import Alert 16-129 (red list)

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As of October 26, 2026, PT Fanwell Wira Mandiri (Jakarta, Indonesia) is on the red list of FDA Import Alert 16-105 (Fish products: decomposition, histamine or indole) for tuna, published by FDA on July 14, 2021, and has 11 FDA import refusals recorded since October 2016.

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

Current status

Last import refusal
Tuna (albacore, yellowfin, bluefin, skipjack, etc.) · HISTAMINE
Last warning letter
None found
Last inspection
None on record

Every FDA record for PT Fanwell Wira Mandiri

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

2021

  1. Import refusal
    Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)HISTAMINEFILTHYEntry AQZ-0511726-5Show 3 lines
    Source
  2. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0509102-3
    Source
  3. Import refusal
    Refused, 3 lines in one entry: Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0511063-3Show 3 lines
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0511063-3Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0511063-3Source
    • Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0511063-3Source
    Source
  4. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0509102-3
    Source
  5. Import refusal
    Refused, Tuna (albacore, yellowfin, bluefin, skipjack, etc.)FILTHYEntry AQZ-0511063-3
    Source
  6. Import alert listing
    Listed on Import Alert 16-105red listTuna
    Source

2020

  1. Import refusal
    Refused, Snapper (red, gray, malabar, etc.)FILTHYEntry 261-0543958-7
    Source

2018

  1. Import refusal
    Refused, Mackerel (only scomberomorus spp eg. spanish or king)FILTHYEntry 991-0236118-7
    Source

Refusal charges, in plain English

  • FILTHY11 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.

  • HISTAMINE3 refused lines

    Histamine

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

Questions about PT Fanwell Wira Mandiri

Is PT Fanwell Wira Mandiri on an FDA import alert?
Yes. As of October 26, 2026, PT Fanwell Wira Mandiri is on the red list of FDA Import Alert 16-105, “Fish products: decomposition, histamine or indole”, for tuna; FDA published the listing on July 14, 2021.
Has FDA refused shipments from PT Fanwell Wira Mandiri?
Yes. FDA refused 11 shipment lines from PT Fanwell Wira Mandiri between July 6, 2018 and November 22, 2021. The most recent, on November 22, 2021, was tuna (albacore, yellowfin, bluefin, skipjack, etc.), charged as HISTAMINE (histamine).
Why did FDA refuse PT Fanwell Wira Mandiri's shipments?
The most frequent charges are FILTHY (filthy, putrid or decomposed substance, 11 lines) and HISTAMINE (histamine, 3 lines).
What is PT Fanwell Wira Mandiri's FEI number?
PT Fanwell Wira Mandiri's FDA Establishment Identifier (FEI) is 3014162861.
Can shipments from PT Fanwell Wira Mandiri still enter the U.S.?
Shipments of tuna from PT Fanwell Wira Mandiri can be detained without physical examination under Import Alert 16-105; 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 Fanwell Wira Mandir 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.