Import Alert 16-04

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 16-04
Published Date: 02/16/2024
Type: DWPE with Surveillance

Import Alert Name:

Detention Without Physical Examination of Seafood Products That Appear To Be Misbranded

Reason for Alert:

NOTE: The revisions to this Import Alert dated 11/22/2021 updates the Import Alert name, Type of Alert, reason for alert, guidance section, product description, charge, and PAF sections. Changes are noted and bracketed by asterisks (***)

*** FDA has found shipments of various species of fish, or other seafood, offered for entry under the name of fictitious, substituted, or otherwise incorrect species.

The Red List of this Alert identifies firms that have imported misbranded seafood products into the United States.

All references to Siluriformes fish (e.g., catfish, basa, tra, swai, etc.) have been removed from this alert because the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) now exercises primary regulatory oversight over Siluriformes fish and fishery products. Through USDA's mandatory inspection program, USDA currently regulates fish of the order Siluriformes and products derived from these fish (9 CFR chapter III subchapter F). Under the FSIS regulation, the labeling only of fish and fishery products within the family Ictaluridae may bear the term "catfish" (9 CFR 541.7(d)(2)). Information regarding catfish can be found on the USDA website at:
http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/siluriformes. ***

Guidance:

***Divisions may detain without physical examination shipments of products identified on the Red List of this Alert.

Seafood products are to be labeled with a suitable statement of identity. FDA recognizes an acceptable market name for a species as a suitable "statement of identity" (21 CFR 101.3). An acceptable market name fairly represents the identity of the species to U.S. consumers because it is not confusingly similar to the name of another species and because it is not otherwise misleading. An acceptable market name may be: (1) a "common or usual name" established by either a history of common usage in the U.S. or by regulation; (2) the "common name;" or (3) more rarely, a name specifically coined as the market name for a species. The term "common name" refers to the English version of the name established and commonly used by ichthyologists and other fishery experts to describe a specific species and is distinct from the scientific name. Almost all species have been assigned a unique common name and its use as the market name has the advantage of limiting confusion about species identity in the marketplace. For this reason, FDA generally recommends use of the common name as the market name unless a common or usual name has been established by regulation or law. There are some common names that are prohibited by law and cannot be used as market names.

Although the scientific name, the Latin name for the genus and species of a fish established by fisheries taxonomists, may uniquely identify a species, it is not, by itself, an acceptable market name. Vernacular names are commonly recognized local or regional names for a species. In many cases, the same species may be recognized by a different name in another locale or region. Vernacular names generally are not acceptable market names.

The Seafood List - FDA's Guide to Acceptable Market Names for Seafood sold in Interstate Commerce (https://www.accessdata.fda.gov/scripts/fdcc/?set=seafoodlist) provides information that may be useful in determining an acceptable market name for a species. Species that are included on The Seafood List are those that FDA has determined are sold in interstate commerce or are likely to be sold in interstate commerce and are not prohibited by law from sale in interstate commerce. The list contains three types of names for each species - acceptable market name, common name, scientific name – as well as unacceptable vernacular name(s) for reference. The Seafood List is not an exhaustive list but is regularly updated, as resources permit.

Seafood products may be misbranded if they are labeled with a fictitious or incorrect common or usual name, including use of vernacular name, or are found, through sampling, to be labeled as another species.***

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the food producer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov ***

*** Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues on policy, sample collection recommendations, or any other questions should be addressed to CFSAN/Division of Enforcement's Dietary Supplement and Labeling Assessment Branch at CFSANEnforcement@fda.hhs.gov ***

Product Description:

***Multiple Seafood Products***

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food. [Misbranding, Section 403(b)]

OASIS charge code - WRONG IDEN

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded, Section 403(a)(1)]

OASIS charge code – FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be. [Misbranded, Section 403(i)(1)]

OASIS charge code – USUAL NAME

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


ARGENTINA


Ardapez SA
Date Published : 08/16/2019
Avenida Virrey Vertiz 3250 , Mar Del Plata, Buenos Aires ARGENTINA
16 A - - 30 Porgy
Date Published: 08/16/2019

Desc: Red Snapper
Notes: The product label on the outside container identifies the species of fish as "Red Snapper".

16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 08/16/2019

Desc: Red Snapper
Notes: The product label on the outside container identifies the species of fish as "Red Snapper"


BANGLADESH


MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2
Date Published : 08/09/2017
Bfdc Plot # 22, Block # B , Ichanagar, Karnafuly , Chattagram, BANGLADESH
16 A - - 09 Carp
Date Published: 08/09/2017

Desc: Large Razor Belly Minnow (Salmostoma bacaila)
Notes: Large Razor Belly Minnow misdeclared as Chalapata

16 A - - 13 Croaker
Date Published: 09/21/2017

Desc: POA; Pama croaker; Otolithoides pama
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 08/09/2017

Desc: Ganges River Sprat (Corica soborna)
Notes: Ganges River Sprat misdeclared as Keski

16 A - - 62 Snake Head
Date Published: 09/21/2017

Desc: TAKI; Spotted snakehead; Channa punctata
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 83 Goby
Date Published: 09/21/2017

Desc: BAILA GURA; tank goby; Glossogobius giuris
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 84 Threadfin
Date Published: 08/09/2017

Desc: Fourfinger Threadfin (Eleutheronema tetradactylum)
Notes: Fourfinger Threadfin misdeclared as Tailla

16 A - - 85 Barramundi
Date Published: 09/21/2017

Desc: DESHI KORAL; barramundi or Asian sea bass; Lates calcarifer
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: MENI; Gangetic leaffish; Nandus nandus
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Fourfinger Threadfin (Eleutheronema tetradactylum)
Notes: Fourfinger Threadfin misdeclared as Tailla

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: TAKI; Spotted snakehead; Channa punctata
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Bombay Duck (Harpadon nehereus)
Notes: Bombay Duck misdeclared as Lotia

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Ganges River Sprat (Corica soborna)
Notes: Ganges River Sprat misdeclared as Keski

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Anchovy /Ramcarat Grenadier Anchovy (Coilia ramcarati)
Notes: Anchovy /Ramcarat Grenadier Anchovy misdeclared as Olwa

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Large Razor Belly Minnow (Salmostoma bacaila)
Notes: Large Razor Belly Minnow misdeclared as Chalapata

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: DESHI KORAL; barramundi or Asian sea bass; Lates calcarifer
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: POA; Pama croaker; Otolithoides pama
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Sardine/White Sardine (Escualosa thoracata)
Notes: Sardine/White Sardine misdeclared as Mola

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Whiting/Sillago/Flat Head Sillago (Sillago domina)
Notes: Whiting/Sillago/Flat Head Sillago misdeclared as Hondra Baila

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Rohu (Labeo rohita)
Notes: Rohu misdeclared as Nola

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Croaker/Pama Croaker (Otolithoides pama)
Notes: Croaker; Pama Croaker misdeclared as Poa

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Calbasu (Labeo calbasu)
Notes: Calbasu misdeclared as Kalibaush

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: BAILA GURA; tank goby; Glossogobius giuris
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 09/21/2017

Desc: FOLI; bronze featherback; Notopterus notopterus
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Olive Barb (Puntius sarana)
Notes: Olive Barb misdeclared as Shor Puti

Seamark (BD) Limited
Date Published : 10/04/2017
Cda Plot No. 50 ,Fouzdarhat Ind. Estate , Sagarika Road , Pahartali , Chittagong, Chittagong zila BANGLADESH
16 A - - 99 Fish, N.E.C.
Date Published: 10/04/2017

Desc: Nola; Rohu; Labeo rohita
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.


BURMA (MYANMAR)


C.K. Frozen Foods Co., Ltd.
Date Published : 12/13/2017
East Dagon Myothit, Yangon, Myanmar , Industrial Zone #1 113; 181 U Shwe Bin Street , Yangon, Yangon BURMA (MYANMAR)
16 A - - 99 Fish, N.E.C.
Date Published: 12/13/2017

Desc: Puti; Olive Barb; Systomus sarana
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

MAY YU MARINE PRODUCTS CO. LTD
Date Published : 06/12/2017
NO.525, MAY YU STREET , INDUSTRIAL ZONE 1 , South Dagon T/s, Yangon BURMA (MYANMAR)
16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Lakka; (Polymemus indicus); Indian Threadfin
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Bata (Mugil cephalus)
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Dry Keski; (Corica soborna); Ganges River Sprat
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Shar Puti; (Systomus sarana); Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Dry Lotia; (Harpadon neherius); Bombay Duck
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Dry Lotia
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Kalibush; (Labeo calbasu); Orangefin Labeo
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/23/2017

Desc: Dry Suri; (Lepturacanthus savala); Small Head Hairtail
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Dry Shoil (Channa striata)
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Carfu (Cyprinus carpio)
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Shoil
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Foly (Notopterus notopterus)
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/12/2017

Desc: Koral (Lates calcarifer);
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

Myint Myat Hein Trading Co., Ltd.
Date Published : 04/28/2017
No.18, Myint Zu Street , Parami Yeikha, Yankin Township , Rangoon, BURMA (MYANMAR)
16 A - - 99 Fish, N.E.C.
Date Published: 04/28/2017

Desc: Shoil (Channa striata)
Notes: The labeling lists Shoil. Shoil is not an acceptable market name or common name for species Channa Striata. Acceptable names are "snakehead;" "channa;" or chevron snakehead."

Shwe Kaba Maung Maung Marine Products Company Ltd.
Date Published : 05/09/2017
no. 132 u mye street and seikkanthar st , zone 4 , Shwe Pyithar T/S, MM-06 BURMA (MYANMAR)
16 A - - 09 Carp
Date Published: 05/09/2017

Desc: Cyprinus carpio (Carfu); Carp
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 09 Carp
Date Published: 08/09/2017

Desc: Carplet; Mola; or Mola Carplet (Amblypharyngodon mola)
Notes: Carplet; Mola; or Mola Carplet misdeclared as Deshi Moilla

16 A - - 23 Mullet
Date Published: 06/09/2017

Desc: Mugil cephalus; Bata; Striped Mullet
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 23 Mullet
Date Published: 06/09/2017

Desc: Mugil cephalus; (Bata); Mullet
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 26 Perch, Fresh Water (Yellow, Lake)
Date Published: 06/09/2017

Desc: Anabas testudineus; (Deshi Koi); Climbing Perch
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 26 Perch, Fresh Water (Yellow, Lake)
Date Published: 06/09/2017

Desc: Anabas testudineus; Deshi Koi; Climbing Perch
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 62 Snake Head
Date Published: 06/09/2017

Desc: Channa striatus; (Shoil); Snakehead or Channa
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 84 Threadfin
Date Published: 06/09/2017

Desc: Polunemus paradiseus; Taposhi; Paradise Threadfin
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 84 Threadfin
Date Published: 06/09/2017

Desc: Leptomelanosoma indicum; (Lakkha); Threadfin
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 85 Barramundi
Date Published: 06/09/2017

Desc: Lates calcarifer; Koral; Dhani Koral; Giant Perch; Barramundi
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 85 Barramundi
Date Published: 06/09/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Labeo calbasu; Kaliboush; Calbasu
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Lates calcarifer; Koral; Dhani Koral; Giant Perch; Barramundi
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Anabas testudineus; Deshi Koi; Climbing Perch
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 05/09/2017

Desc: Cyprinus carpio (Carfu); Carp
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Puntius sarana; Puta; Shorputi; Olive Barb
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Bombay Duck (Harpadon nehereus)
Notes: Bombay Duck misdeclared as Dry Lottia

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Mugil cephalus; Bata; Striped Mullet
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Puntius sarana; (Puta); Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 06/09/2017

Desc: Polunemus paradiseus; Taposhi; Paradise Threadfin
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Anabas testudineus; Deshi Koi; Climbing Perch
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Puntius sarana; Puta; Shorputi; Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Lates calcarifer; Koral; Dhani Koral; Giant Perch; Barramundi
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Mugil cephalus; Bata; Striped Mullet
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Labeo calbasu; Kaliboush; Calbasu
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 06/09/2017

Desc: Polunemus paradiseus; Taposhi; Paradise Threadfin
Notes: Problem(s);The label fails to bear the common or usual name of the food; if any there be.

Shwe Myanamar Investment and Commercial Co., Ltd.
Date Published : 07/13/2017
South Dagon Township , No. 92 U Pho Hlaing Street , Yangon, Yangon BURMA (MYANMAR)
16 A - - 08 Butterfish
Date Published: 07/13/2017

Desc: Pampus Argenteus; (WP) Silver or White Pomfret
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 09 Carp
Date Published: 07/13/2017

Desc: Cyprinus carpio (Carfu); Carp
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 62 Snake Head
Date Published: 07/13/2017

Desc: Channa striata; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 84 Threadfin
Date Published: 07/13/2017

Desc: Lakka; (Polymemus indicus); Indian Threadfin
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 85 Barramundi
Date Published: 07/13/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 99 Fish, N.E.C.
Date Published: 07/13/2017

Desc: Channa striata; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 99 Fish, N.E.C.
Date Published: 07/13/2017

Desc: Lakka; (Polymemus indicus); Indian Threadfin
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 99 Fish, N.E.C.
Date Published: 07/13/2017

Desc: Pampus Argenteus; (WP) Silver or White Pomfret
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 99 Fish, N.E.C.
Date Published: 07/13/2017

Desc: Puntius sarana; (Puti); Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be

16 A - - 99 Fish, N.E.C.
Date Published: 07/13/2017

Desc: Cyprinus carpio (Carfu); Carp
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

YADANAR THEINGI FACTORY PROCESSING PLANT
Date Published : 07/21/2017
Insein Township, Yangon, Myanmar , No. 9 Bayint Naung Road, West Gyogone , Yangon, Yangon BURMA (MYANMAR)
16 A - - 62 Snake Head
Date Published: 07/21/2017

Desc: Lates calcarifer; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 85 Barramundi
Date Published: 07/21/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Puti); Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

Yadanar Theingi Co. Ltd
Date Published : 07/21/2017
286 ,G.Fl Shwedagon Pagoda Road , Yangon, BURMA (MYANMAR)
16 A - - 62 Snake Head
Date Published: 07/21/2017

Desc: Lates calcarifer; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 85 Barramundi
Date Published: 07/21/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Shoil); Snakehead Murrel
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Koral); Barramundi
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 A - - 99 Fish, N.E.C.
Date Published: 07/21/2017

Desc: Lates calcarifer; (Puti); Olive Barb
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.


CANADA


Connors Bros
Date Published : 02/16/2024
180 Brunswick St , Blacks Harbour, New Brunswick CANADA
16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 02/16/2024

Desc: Sardines in Oil
Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food as required by 21 CFR 101.3(b). Specifically, the statement of identity indicates “sardines” while the ingredient statement states “herring.” Herring and sardines are not the same fish. The acceptable market names of sardines and herring may not be used interchangeably for this product.

J.S. Mcmillan Fisheries
Date Published : 05/28/2013
4509 Mcdonald Rd , Vancouver, BC CANADA
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 05/28/2013

Desc: Snapper
Notes: Problem; Ocean Perch Sebastes alutus was mislabeled as Pacific Snapper


CHINA


Shanghai Xin Chen Da Industrial Development Co. Ltd.
Date Published : 12/17/2020
Room 1301, Building 1, No.1318, Zhouzhugong Road , Pudong New Area , Shanghai, Shanghai CHINA
16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products
Date Published: 12/17/2020

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The label fails to bear the common or usual name of the food, if any there be. Ingredient: "Black Fish Fillet"

Suzhou Shui Tian Tang Food Production Co., Ltd.
Date Published : 12/17/2020
No 11 Guanshan Road , High-Tech District , Suzhou, Jiangsu CHINA
16 W - - 15 Fish chowder/soup/stew/bisque, Mixed Fishery/Seafood Products
Date Published: 12/17/2020

Desc: Frozen Soup "FROZEN FISH WITH PICKLED MUSTARD GREEN"
Notes: The label fails to bear the common or usual name of the food, if any there be. Ingredient: "Black Fish Fillet"

XIA WEI AQUATIC PRODUCT CO., LTD.
Date Published : 09/18/2009
A Dong Room 401 , Yilingsi National Highway; Fuding , Ningde, Fujian CHINA
16 A - - 14 Cusk
Date Published: 09/30/2019

Desc: Puffer fish (BOK) misdeclared as "Monk Fish"
Notes: 10/18/2007


DENMARK


POLAR SEAFOODS DK A/S
Date Published : 01/02/2020
Baldrianvej 2 , Vodskov, Nordjylland DENMARK
16 A - - 20 Halibut
Date Published: 01/02/2020

Desc: Halibut
Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.

16 A - - 46 Turbot
Date Published: 01/02/2020

Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.


GREENLAND


Polar Raajat A/S
Date Published : 01/02/2020
Box 1599 , Nuuk, GREENLAND
16 A - - 20 Halibut
Date Published: 01/02/2020

Desc: Halibut
Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.

16 A - - 46 Turbot
Date Published: 01/02/2020

Desc: Turbot
Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.

Polar Raajat A/S - Aasiaat
Date Published : 01/02/2020
Tipitooq 1 , Kangilleq , Aasiaat, Qaasuitsup Kommunia GREENLAND
16 A - - 20 Halibut
Date Published: 01/02/2020

Desc: Halibut
Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.

16 A - - 46 Turbot
Date Published: 01/02/2020

Desc: Turbot
Notes: The product label identifies the species of fish as "Greenland Halibut" and Latin name Reinhardtius hippoglossoides which can only be used to describe Greenland turbot.


INDIA


BLUE-FIN FROZEN FOODS
Date Published : 05/09/2017
Plot No , L - 72 Mumbai Pune Road , Panvel, Maharashtra INDIA
16 A - - 99 Fish, N.E.C.
Date Published: 05/09/2017

Desc: Lotia; Harpodon nehereus; Bombay duck; Bummalo; Lizardfish
Notes: Problem(s): The label fails to bear the common or usual name of the food, if any there be.

Keshodwala Foods (Unit 2)
Date Published : 06/16/2016
Plot No 306 Gidc Estate , Veraval, Gujarat INDIA
16 A - - 99 Fish, N.E.C.
Date Published: 06/16/2016

Desc: Beltfish
Notes: Problem(s); At entry product is declared as "Frozen Whole Ribbonfish" (Lepturacanthus savala); product labeling declares product as "Beltfish; Head-On". Lepturacanthus savala is the scientific name for "Cutlassfish" (market name) and "smallhead hairtail" (common name).

16 A - - 99 Fish, N.E.C.
Date Published: 06/16/2016

Desc: Frozen Whole Ribbonfish (Lepturacanthus savala)
Notes: Problem(s);At entry product is declared as "Frozen Whole Ribbonfish" (Lepturacanthus savala); product labeling declares product as "Beltfish; Head-On".Lepturacanthus savala is the scientific name for "Cutlassfish" (market name) and "smallhead hairtail" (common name).

Parayil Food Products Pvt. Ltd.
Date Published : 08/11/2017
Alleppey , Aroor, Kerala INDIA
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 08/11/2017

Desc: Red Snapper Steak; Twinspot Snapper; Lutjanus bohar
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.


INDONESIA


PT Kelola Biru H
Date Published : 04/26/2023
Jln. Komplek Industri Volker Dua , Jakarta, Jakarta INDONESIA
16 A - - 63 Kingfish (only Menticirrhus spp)
Date Published: 04/26/2023

Desc: King Fish
Notes: “King Fish” is declared on product label. Product is actually Scomberomorus commerson and per the FDA Seafood List the acceptable market or common name for this species is Mackerel, Spanish Mackerel, or Narrow-barred Mackerel.

16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 04/26/2023

Desc: King Fish
Notes: “King Fish” is declared on product label. Product is actually Scomberomorus commerson and per the FDA Seafood List the acceptable market or common name for this species is Mackerel, Spanish Mackerel, or Narrow-barred Mackerel.

16 A - - 78 Wahoo
Date Published: 04/26/2023

Desc: King Fish
Notes: “King Fish” is declared on product label. Product is actually Scomberomorus commerson and per the FDA Seafood List the acceptable market or common name for this species is Mackerel, Spanish Mackerel, or Narrow-barred Mackerel.

PT. Alam Jaya
Date Published : 06/12/2023
Jln. Rungkut Industri Ii No. 25 , Surabaya, Jawa Timur INDONESIA
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 06/12/2023

Desc: Snapper Red Snapper
Notes: Lab analysis revealed the product from this manufacturer to be labeled as "Red Snapper" but were a species of fish that cannot be labeled "Red Snapper" per FDA's Seafood List database. The analysis found the fish to be either Lutjanus malabaricus, which have the FDA Acceptable Market name of "Malabar Snapper" or “Snapper” or Lutjanus erythropterus, which have the FDA Acceptable Market name of "Crimson Snapper" or “Snapper”.

PT. Global Maju Pratama
Date Published : 01/18/2024
Pattene Business Park Blok H No. 2 , Maros, Sulawesi Selatan INDONESIA
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 01/18/2024

Desc: Red Snapper
Notes: Problem(s): Product label declared the product as "Red Snapper, Lutjanus malabaricus”, which has an acceptable market name of "Snapper" and a common name of "Malabar Snapper".


JAPAN


Koyo Trading Ltd.
Date Published : 09/18/2009
7f Daiko Bldg. , Tsukiji , Chuo, Tokyo JAPAN
16 A - - 17 Groupers
Date Published: 09/18/2009

Notes: Puffer Fish (Fugu) misdeclared as Grouper

16 A - - 65 Puffer
Date Published: 09/18/2009

Notes: Puffer Fish (Fugu) misdeclared as Grouper

NAKAYAMA SHOTEN
Date Published : 09/18/2009
3 Chome 14-2 , Nagahama; Chuo , Fukuoka, Fukuoka JAPAN
16 A - - 17 Groupers
Date Published: 09/18/2009

Notes: Puffer Fish (Fugu) misdeclared as Grouper

16 A - - 65 Puffer
Date Published: 09/18/2009

Notes: Puffer Fish (Fugu) misdeclared as Grouper


MALAYSIA


Supersea Fish Centre Sdn. Bhd.
Date Published : 09/18/2009
12 Taman Lahat Baru 10 , Ipoh, Perak MALAYSIA
16 A - - 17 Groupers
Date Published: 09/18/2009

Notes: Pangasius species misdeclared as Grouper Fillet


MEXICO


JORGE AVEL SAUCEDA GARCIA
Date Published : 08/15/2013
Nogal 150 , Fracc. RUBIO , Tijuana, BC MEXICO
16 M - - 99 Other Aquatic Animals, N.E.C.
Date Published: 08/15/2013

Desc: Skate Wing
Notes: MANUFACTURER -- Salva Mar, S.A. - FEI #2000027744; PROBLEM -- Product described as "Filete de Mantaraya" on labeling. Product described as "frozen fillet of skate wing" and "frozen manta ray fillets" in entry documents. FDA determined the product appear to be stingray.

16 M - - 99 Other Aquatic Animals, N.E.C.
Date Published: 08/15/2013

Desc: Manta Ray
Notes: MANUFACTURER -- Salva Mar, S.A. - FEI #2000027744; PROBLEM -- Product described as "Filete de Mantaraya" on labeling. Product described as "frozen fillet of skate wing" and "frozen manta ray fillets" in entry documents. FDA determined the product appear to be stingray.

Rodrigo C Aguirre
Date Published : 07/21/2015
Avenida Estado 29 # 2598 , Ampl. Ampl Hidalgo, Ensenada , Ensenada, Baja California MEXICO
16 A - - 55 Corvina
Date Published: 07/21/2015

Desc: Dry Fish Maw; Corvina
Notes: Problem(s); FDA analysis identified samples 908641 and 910642 to be a mixture of weakfish/corvina (2 different Cynoscion spp.) and snook (2 different Centropomus spp.)


NEW ZEALAND


Moana Pacific Fisheries
Date Published : 05/30/2013
138 Halsey Street , P.O. Box 445 , Auckland, Nz-Auk NEW ZEALAND
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 05/30/2013

Desc: PORGY/SEABREAM MISDECLARED AS; TAI SNAPPER

SEI Limited
Date Published : 05/30/2013
43 Kupe Drive , Whitianga, NEW ZEALAND
16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 05/30/2013

Desc: PORGY/SEABREAM MISDECLARED AS; TAI SNAPPER


PANAMA


Salva Mar, S.A.
Date Published : 08/15/2013
Boca Parita Port , Monagrillo , Chitre District, Herrera Province PANAMA
16 M - - 99 Other Aquatic Animals, N.E.C.
Date Published: 08/15/2013

Desc: Skate Wing
Notes: SHIPPER -- Jorge Avel Sauceda Garcia - FEI #3010049573; PROBLEM -- Product described as "Filete de Mantaraya" on labeling. Product described as "frozen fillet of skate wing" and "frozen manta ray fillets" in entry documents. FDA determined the product appear to be stingray.

16 M - - 99 Other Aquatic Animals, N.E.C.
Date Published: 08/15/2013

Desc: Manta Ray
Notes: SHIPPER -- Jorge Avel Sauceda Garcia - FEI #3010049573; PROBLEM -- Product described as "Filete de Mantaraya" on labeling. Product described as "frozen fillet of skate wing" and "frozen manta ray fillets" in entry documents. FDA determined the product appear to be stingray.


PERU


Maquimar S.A.
Date Published : 09/18/2009
Avenida Acapulco No. 150 , Callao, Callao PERU
16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 09/18/2009

Notes: menhaden in tomato sauce declared as sardines in tomato sauce

16 A - - 99 Fish, N.E.C.
Date Published: 09/18/2009

Notes: Anchovies (in tomato sauce) misdeclared as " Pamplona Sardines in tomato Sauce"


PHILIPPINES


PIXCEL TRANSGLOBAL FOODS INC
Date Published : 05/12/2017
808 Dalisay Street , Caloocan City, National Capital Region PHILIPPINES
16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 05/12/2017

Desc: Lutong Bahay Ziganid (Padas)
Notes: Labeling lists Padas or Ziganid; these are vernacular names. In FDA's Seafood List; the acceptable market name "spinefoot" or the common name rabbitfish is to be use for the Siganus fish species.


THAILAND


B.S.A.FOOD PRODUCTS CO.,LTD
Date Published : 08/09/2017
Bangya Coldstorage , 1278 Wichienchodok Road , Muang Samut Sakhon, Samut Sakhon THAILAND
16 A - - 24 Ocean Perch (Red Perch, Pacific Perch, Redfish)
Date Published: 08/09/2017

Desc: Climbing Perch (Anabas testudineus)
Notes: Climbing Perch misdeclared as Koi

16 A - - 99 Fish, N.E.C.
Date Published: 08/09/2017

Desc: Climbing Perch (Anabas testudineus)
Notes: Climbing Perch misdeclared as Koi

16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Gura Essa;" Litopenaeus vannamei; Pacific White Shrimp; King Prawn.
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Dima;" Macrobrachium rosenbergii; Giant River Prawn; Giant Freshwater Prawn.
Notes: Problem(s): The label fails to bear the common or usual name of the food, if any there be.

16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Gura Fish;" Litopenaeus vannamei; Pacific White Shrimp; King Prawn.
Notes: Problem(s); The label fails to bear the common or usual name of the food; if any there be.

B.S.A.FOOD PRODUCTS CO.,LTD
Date Published : 09/05/2018
Bangya Coldstorage , 1278 Wichienchodok Road , Muang Samut Sakhon, Samut Sakhon THAILAND
16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Gura Essa;" Litopenaeus vannamei; Pacific White Shrimp; King Prawn.
Notes: Problem(s): The label fails to bear the common or usual name of the food, if any there be.

16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Gura Fish;" Litopenaeus vannamei; Pacific White Shrimp; King Prawn.
Notes: Problem(s): The label fails to bear the common or usual name of the food, if any there be.

16 J - - 05 Shrimp & Prawns
Date Published: 09/05/2018

Desc: "Dima;" Macrobrachium rosenbergii; Giant River Prawn; Giant Freshwater Prawn.
Notes: Problem(s): The label fails to bear the common or usual name of the food, if any there be.


URUGUAY


Trymmur Ltda
Date Published : 09/18/2009
Av.Dr.Luis a. de Herrera 3909 , Montevideo, Montevideo URUGUAY
16 A - - 35 Shark
Date Published: 09/18/2009

Notes: Mako shark misdeclared Edificio Torre Libertad as " White Fish"


VIETNAM


ANHACO
Date Published : 09/18/2009
KM 09 PROVINCE ROAD NO. 883 , CHAUTHANH DISTRICT , BEN TRE, VN-50 VIETNAM
16 A - - 09 Carp
Date Published: 09/18/2009

Notes: Panagasius species misdeclare as "Carp Fillet"

Angiang Agricultural Technology Service Company, The
Date Published : 09/18/2009
69-71-73 Nguyen Hue B, Longxuyen, , Angiang, Vietnam, VIETNAM
16 A - - -- Fish
Date Published: 09/18/2009

16 B - - -- Fish,Breaded
Date Published: 09/18/2009

16 C - - -- Fish,Cakes,Balls,etc
Date Published: 09/18/2009

16 I - - -- Fish, Hot Smoked (protein is coagulated throughout
Date Published: 09/18/2009

16 S - - -- Fish, Cold Smoked (protein is not coagulated)
Date Published: 09/18/2009

16 W - - -- Mixed Fishery/Seafood Products
Date Published: 09/18/2009

16 X - - -- Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/18/2009

16 Y - - -- Fishery Prod,n.e.c.
Date Published: 09/18/2009

Bach Thao Co., Ltd.
Date Published : 09/18/2009
No.9 Nguyen An Ninh Street , Binh Khanh Ward , Long Xuyen City, An Giang VIETNAM
16 A - - 58 Tilapia
Date Published: 09/18/2009

Notes: Pangasius species as tilapia Fillets

16 X - - 06 Tilapia, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/18/2009

Notes: Pangasius species as tilapia Fillets

Hoang Huy Production Trading Service
Date Published : 08/15/2016
35 Phan Chu Trinh , Quy Nhon, VN-31 VIETNAM
16 A - - 63 Kingfish (only Menticirrhus spp)
Date Published: 08/15/2016

Desc: Frozen Pacific Kingfish; "Five Star" and "Seafresca"
Notes: Product fails to bear the common or usual name of the fish; Product is declared as "Kingfish" at entry. Product packaging identifies the fish species as "Acanthocybium solandri" which is Wahoo; not Kingfish. Product Nutrition facts panel in not is an appropriate format.

INVESTMENT COMMERCE FISHERIES CORPORATION
Date Published : 01/21/2020
Binh Tan District , A77/I, Road No 7, Vinh Loc Industrial Park , Ho Chi Minh, Ho Chi Minh VIETNAM
16 A - - 36 Smelt
Date Published: 01/21/2020

Desc: FROZEN SMELT FISH H/G Rasbora borapetensis wild caught
Notes: The label fails to bear the common or usual name of the food, if any there be. Correct description for Rasbora borapetensis is "carp" or "red tailed rasbora".

Mekong Fisheries
Date Published : 09/18/2009
Lot 24, Tra Noc Industrial Zone , Binh Thuy District, Can Tho, VN-NOTA VIETNAM
16 A - - 77 Sole
Date Published: 09/18/2009

Notes: Pangasius species misdeclared as " IQF Sole Fillets"

SAI THANH COMPANY LIMITED
Date Published : 02/04/2020
283/12, Le Duc Tho St. , Go Vap Dist. , Ho Chi Minh, VIETNAM
16 A - - 07 Bonito
Date Published: 02/04/2020

Desc: Bonito (Wild Caught) Ca Ngu Bong
Notes: Inner and outer carton labeling don't agree; Outer carton; Auxis thazard, "Bonito". Inner package; Bonito, Ca Ngu Bong. Auxis thazard is Tuna, not Bonito.

Southern Fresh Foods Co., Ltd
Date Published : 03/24/2023
Lot La1, Street 1, Xuyen A Industrial Park , My Hanh Bac Commune , Duc Hoa District, VN-41 VIETNAM
16 A - - 99 Fish, N.E.C.
Date Published: 03/24/2023

Desc: Silver Fish; Salangidae; Icefish; Noodlefish
Notes: “Silver Fish” declared on product label is not an acceptable market or common name.