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Nara Co.,Ltd.

FDA import alert and refusal historyIbusuki, JapanFEI 3004249809

Recorded by FDA as NARA CO.,LTD.; Nara Company Ltd.

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

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As of October 25, 2026, Nara Co.,Ltd. (Ibusuki, Japan) is on the red list of FDA Import Alert 16-120 (Seafood from processors not in compliance with HACCP) for yellowtail/amberjack; fish; aquaculture; co processed; buri fish; co processed, published by FDA on June 5, 2024, and has 33 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 list
Last import refusal
Yellowtail, amberjack · MFRHACCP
Last warning letter
Seafood HACCP/CGMP for Foods/Adulterated
Last inspection
Classified OAI (Official Action Indicated)

Every FDA record for Nara Co.,Ltd.

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

2025

  1. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 235-8061191-3
    Source

2024

  1. Import refusal
    Refused, 5 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 235-8060956-0Show 5 lines
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4131286-2Show 2 lines
    Source
  3. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 510-4135939-2
    Source
  4. Import refusal
    Refused, 2 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4134317-2Show 2 lines
    Source
  5. Import refusal
    Refused, 2 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4130647-6Show 2 lines
    Source
  6. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 510-4132193-9
    Source
  7. Import refusal
    Refused, 2 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4130451-3Show 2 lines
    Source
  8. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 510-4127750-3
    Source
  9. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 510-4130451-3
    Source
  10. Import refusal
    Refused, 2 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4127750-3Show 2 lines
    Source
  11. Import refusal
    Refused, Yellowtail, amberjackMFRHACCPEntry 510-4130451-3
    Source
  12. Import refusal
    Refused, 9 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 235-1724254-3Show 9 lines
    Source
  13. Import refusal
    Refused, 3 lines in one entry: Yellowtail, amberjackMFRHACCPEntry 510-4121990-1Show 3 lines
    Source
  14. Import alert listing
    Listed on Import Alert 16-120red listYellowtail/Amberjack; Fish; aquaculture; CO processed; Buri Fish; CO processed
    Source
Show 3 earlier records (2009–2023)

2023

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

2022

  1. Inspection
    Inspection classified OAI (Official Action Indicated)Foodborne Biological Hazards
    Source

2009

  1. Inspection
    Inspection classified OAI (Official Action Indicated)Foodborne Biological Hazards
    Source

Refusal charges, in plain English

  • MFRHACCP33 refused lines

    Seafood HACCP requirements not met

    The seafood appeared to have been processed without meeting the seafood HACCP requirements in 21 CFR 123.6(a) and 123.8(a), so it is treated as prepared under insanitary conditions.

Questions about Nara Co.,Ltd.

Is Nara Co.,Ltd. on an FDA import alert?
Yes. As of October 25, 2026, Nara Co.,Ltd. is on the red list of FDA Import Alert 16-120, “Seafood from processors not in compliance with HACCP”, for yellowtail/amberjack; fish; aquaculture; co processed; buri fish; co processed; FDA published the listing on June 5, 2024.
Has FDA refused shipments from Nara Co.,Ltd.?
Yes. FDA refused 33 shipment lines from Nara Co.,Ltd. between July 5, 2024 and January 28, 2025. The most recent, on January 28, 2025, was yellowtail, amberjack, charged as MFRHACCP (seafood haccp requirements not met).
Why did FDA refuse Nara Co.,Ltd.'s shipments?
The most frequent charge is MFRHACCP (seafood haccp requirements not met, 33 lines).
Has Nara Co.,Ltd. received an FDA warning letter?
Yes. FDA issued a warning letter to Nara Co.,Ltd. on February 7, 2023 (Seafood HACCP/CGMP for Foods/Adulterated).
When was Nara Co.,Ltd. last inspected by FDA?
FDA's most recent inspection of Nara Co.,Ltd. with a final classification is dated September 7, 2022 and was classified OAI (Official Action Indicated).
What is Nara Co.,Ltd.'s FEI number?
Nara Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3004249809.
Can shipments from Nara Co.,Ltd. still enter the U.S.?
Shipments of yellowtail/amberjack; fish; aquaculture; co processed; buri fish; co processed from Nara Co.,Ltd. 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 subjectNara 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.