Big Two, Inc.
FDA import alert and refusal historyOta, JapanFEI 3007907658
Recorded by FDA as BIG TWO, INC.
As of October 26, 2026, Big Two, Inc. (Ota, Japan) is on the red list of FDA Import Alert 16-74 (Uneviscerated salt-cured, dried, smoked or fermented fish) for dried sailfin sandfish; arctoscopus japonicas; "hatahata maruboshi", published by FDA on December 23, 2016, is also listed on Import Alert 16-39 (red list), and has 1 FDA import refusal recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 16-74 · red listIA 16-39 · red list
- Last import refusal
- Fish, n.e.c. · LIST INGRE
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Big Two, Inc.
3 records, newest first. Each line links to the FDA page it came from.
2016
- Import alert listingListed on Import Alert 16-74red listDried Sailfin Sandfish; Arctoscopus japonicas; "Hatahata Maruboshi"Source
- Import refusalRefused, Fish, n.e.c.LIST INGREINCONSPICULISTERIAMFR INSANEntry 9XL-0100840-1Source
- Import alert listingListed on Import Alert 16-39red listDried Sailfin SandfishSource
Refusal charges, in plain English
- INCONSPICU1 refused line
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.
- 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).
- LISTERIA1 refused line
Listeria monocytogenes
The product appeared to contain Listeria monocytogenes, which the law treats as a poisonous and deleterious substance that may make food injurious to health.
- MFR INSAN1 refused line
Insanitary manufacturing, processing or packing
The product appeared to have been manufactured, processed, or packed under insanitary conditions, which is a ground for refusal under section 801(a)(1) of the FD&C Act.
Questions about Big Two, Inc.
- Is Big Two, Inc. on an FDA import alert?
- Yes. As of October 26, 2026, Big Two, Inc. is on the red list of FDA Import Alert 16-74, “Uneviscerated salt-cured, dried, smoked or fermented fish”, for dried sailfin sandfish; arctoscopus japonicas; "hatahata maruboshi"; FDA published the listing on December 23, 2016.
- Has FDA refused shipments from Big Two, Inc.?
- Yes. FDA refused 1 shipment line from Big Two, Inc. on December 20, 2016. The most recent, on December 20, 2016, was fish, n.e.c., charged as LIST INGRE (ingredients not listed).
- Why did FDA refuse Big Two, Inc.'s shipments?
- The most frequent charges are INCONSPICU (required information not conspicuous, 1 line) and LIST INGRE (ingredients not listed, 1 line).
- What is Big Two, Inc.'s FEI number?
- Big Two, Inc.'s FDA Establishment Identifier (FEI) is 3007907658.
- Can shipments from Big Two, Inc. still enter the U.S.?
- Shipments of dried sailfin sandfish; arctoscopus japonicas; "hatahata maruboshi" from Big Two, Inc. can be detained without physical examination under Import Alert 16-74; 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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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.