Import Alert 16-25

(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 # 16-25
Published Date: 10/25/2024
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Processed Crabmeat from Thailand"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 07/27/2021 updates the name of the alert, guidance, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***).

In the six-month period from July 7, 1980, to January 9, 1981, there were 21 detentions of canned crabmeat from Thailand, due to insect, rodent, bird, cat and other filth. These detentions represent shipments from several different packers. FY 91 detentions data supports continuation of this import alert as shipments continued to be refused.

It has become apparent that crabmeat from Thailand is being imported in additional types of containers other than metal cans. Because filth is associated with the product and not container specific, the import alert has been expanded to encompass additional product processes and all container types (i.e., metal, plastic, paper waxed, fiber board, etc.).

Guidance:

Divisions may detain, without physical examination, all processed crabmeat in containers (metal, plastic, paper waxed fiber board) from Thailand, except from those firms and products (where specified) listed on the Green List which are exempt from detention without physical examination.

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment identified for DWPE under this import alert, the owner or consignee of the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not contain filth at a level that is determined to be filthy within the meaning of Section 402(a)(3) of the Federal Food, Drug & Cosmetic Act.

Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's website for Private Laboratory Testing and FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):

In order to add a firm's product to the Green List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. This can include written preventive controls, monitoring records, and if the condition is pre-existing, a root cause analysis identifying the source or potential sources of contamination. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third-party laboratory analysis of a representative sample of the lot verifying that products do not contain filth.

For further guidance on removal from detention without physical examination (DWPE), refer to FDA's 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 detention without physical examination 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, be sent via email to: Importalerts2@fda.hhs.gov ***

***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@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 with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov ***

Product Description:

Processed crabmeat (in all container types)

Charge:

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. [Adulteration, Section 402(a)(3)]***

OASIS charge code: FILTHY

Countries

THAILAND

  • (16 J - N 01) Crab, Heat Treated
  • (16 J - O 01) Crab, Pasteurized
  • (16 J - T 01) Crab, Packaged Food (Not Commercially Sterile)
  • (16 J - E 01) Crab, Commercially Sterile
  • (16 J - I 01) Crab, Acidified

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


THAILAND


Bangkok Universal Trading Corporation Ltd
Date Published : 09/18/2009
Unknown , Bangkok, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

Notes:                

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

Notes:                

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

Notes:                

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

Notes:                

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Notes:                

Eastern Star Marine Co., Ltd.
Date Published : 09/18/2009
99, Moo 9, Bangkradam-Tajod Road , Saentoong , Khaosaming, TH-23 THAILAND
16 J - - 01 Crab
Date Published: 01/07/2021

Desc: Pasteurized Crabmeat
Notes: 11/5/2004

Gulf Coast Crab International Co. Ltd.
Date Published : 09/18/2009
Tambon Nongkhansong , Tambon Nongkhansong , Mueang Trat, Trat THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 09/18/2009

Notes: Exempt - 11/2/2000

16 J - I 01 Crab, Acidified
Date Published: 09/18/2009

Notes: Exempt - 11/2/2000

16 J - N 01 Crab, Heat Treated
Date Published: 09/18/2009

Notes: Exempt - 11/2/2000

16 J - O 01 Crab, Pasteurized
Date Published: 09/18/2009

Notes: Exempt - 11/2/2000

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 09/18/2009

Notes: Exempt - 11/2/2000

I-TAIL CORPORATION PUBLIC COMPANY LIMITED Limited Company
Date Published : 09/18/2009
333 Moo 2, Kamjanavanich Road , Mueang Songkhla, Songkhla THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 9/12/2007

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 9/12/2007

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 9/12/2007

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 9/12/2007

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 9/12/2007

Kingfisher Holding Limited
Date Published : 01/20/2010
Mahachai, Muang , 1261 Vichienchidok Rd. , Muang Samut Sakhon, Samut Sakhon THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

MAHACHAI MARINE PRODUCTS
Date Published : 09/18/2009
56/5 Moo 3 Soi Wat Srimuang , Muang District, Samut Sakhon THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

Notes: Exempt - 12/4/2001

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

Notes: Exempt - 12/4/2001

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

Notes: Exempt - 12/4/2001

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

Notes: Exempt - 12/4/2001

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Notes: Exempt - 12/4/2001

MMP International Co. Ltd.
Date Published : 09/18/2009
19/8 , Thanon Nadee Soi 6 , Mueang Samut Sakhon, Samut Sakhon THAILAND
16 J E E 01 Crab, Metal, Commercially Sterile
Date Published: 01/11/2021

Desc: Canned Crabmeat
Notes: 7/25/2007

N R Instant Produce Co Ltd
Date Published : 09/18/2009
75 Thanon Ko Mo Soi 12 , Krathum Baen, Samut Sakhon THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Crab Paste with Bean Oil
Notes: 7/22/2004 (exempt)

Noumea Food Company Ltd
Date Published : 09/18/2009
1741 Rama Iv Road , Bangkok, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Pakfood #1
Date Published : 09/18/2009
Tambon Nadee , 30 Ekachai Rd. , Muang Samut Sakhon, Samut Sakhon THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

Pakfood Public Co. Ltd.
Date Published : 09/18/2009
Moo 3 , 320 Sunanant Rd. , West Pakpanang, Nakhon Si Thammarat THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Notes: Exempt - 2/13/2002

Pan Asia (1981) Co., Ltd.
Date Published : 09/18/2009
Takarm District, Punpin , 17 Charoenlarp Road , Suratthani, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Pan Asia (1981) Co. Ltd.
Date Published : 09/18/2009
814 Sukhumvit 103 , Prawet, Bangkok THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/20/2010

16 J - I 01 Crab, Acidified
Date Published: 01/20/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/20/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/20/2010

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/20/2010

Pantainorasingh Manufacturer Co., Ltd.
Date Published : 09/18/2009
Moo 2 , 99 Tambol Galoong , Muang Samut Sakhon, Samut Sakhon THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Crab paste in soybean oil
Notes: 9-20-2004 (exempt)

Pantainorasingh Manufacturer Co., Ltd.
Date Published : 09/18/2009
920 , 33-35 Ekachai Road , Muang Samut Sakhon, Samut Sakhon THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Crab paste with soybean oil
Notes: 07/13/2004 (exempt)

Phillips Seafoods (Thailand) Co Ltd
Date Published : 09/18/2009
61/9 Moo 1 Ratanakosin 200 Years Road , Ranong, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 1/20/1999

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 1/20/1999

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 1/20/1999

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 1/20/1999

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 1/20/1999

16 J - - 01 Crab
Date Published: 09/13/2011

Desc: Crab

Phillips Seafoods (Thailand) Co., Ltd.
Date Published : 01/19/2012
8 Moo 5 Chonlachram Road , Surat Thani, Surat Thani THAILAND
16 J - - 01 Crab
Date Published: 01/19/2012

Desc: Crab

Royal Sea Products
Date Published : 09/18/2009
Banpu , 132; 1 Kanchanavanich Road , Hat Yai, Songkhla THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 9/26/2002

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 9/26/2002

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 9/26/2002

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 9/26/2002

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 9/26/2002

Samui Foods Co., Ltd.
Date Published : 09/18/2009
84 , 153 Room1212, Le Jardin , Chatuchak, Bangkok THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

Samui Foods Co., Ltd.
Date Published : 09/18/2009
T. Makamitia , 15/1 Moo, 6 Bandon-Nasan Road , Suratthani, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 3/30/2000

Sichon Daily Fresh
Date Published : 09/18/2009
323/6 , Moo 4; Tambon Phothong , Tha Sala, Nakhon Si Thammarat THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Chilled Processed Crabmeat
Notes: 6/29/2009 (exempt)

Spi Canning Co., Ltd.
Date Published : 01/21/2010
275 Bangpoo Industria Estate Moo (soi) 4 , Praeksa, Samutprakan, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 6/15/1993

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 6/15/1993

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 6/15/1993

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 6/15/1993

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 6/15/1993

Supsongphol Enterprise Co., Ltd.
Date Published : 09/18/2009
99 Moo 9 Bangkradan-Tajod Rd. , T. Saentoong , Khaosaming, Th-23 THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Pasteurized crabmeat
Notes: 9/13/2007 (exempt)

Tai Yu Products Co. (Thailand) Ltd.
Date Published : 09/18/2009
1665 Therd Thai Road , Bangkok, THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/15/2021

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

The Peace Canning Co., Ltd.
Date Published : 09/18/2009
88 Moo5 Chiangmai-Proud Road , Sansai, Chiang Mai THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Trang Sure Co Ltd.
Date Published : 09/18/2009
88 , 8 M0004 Kuang Pei San Road , T.Nathamneau, Trang THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 9/21/2000

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 9/21/2000

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 9/21/2000

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 9/21/2000

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 9/21/2000

Tropical Canning (Thailand) Public Company
Date Published : 09/18/2009
1 , 2 Thanon Punnagan -Thungdon , Hat Yai, Songkhla THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 9/12/1995

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 9/12/1995

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 9/12/1995

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 9/12/1995

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 9/12/1995

V. Thai Food Product Co., Ltd.
Date Published : 09/18/2009
221 Moo.1 Thanon Suk Sawat , Phra Samut Chedi, Samut Prakan THAILAND
16 J - E 01 Crab, Commercially Sterile
Date Published: 01/21/2010

Notes: Exempt - 5/6/2005

16 J - I 01 Crab, Acidified
Date Published: 01/21/2010

Notes: Exempt - 5/6/2005

16 J - N 01 Crab, Heat Treated
Date Published: 01/21/2010

Notes: Exempt - 5/6/2005

16 J - O 01 Crab, Pasteurized
Date Published: 01/21/2010

Notes: Exempt - 5/6/2005

16 J - T 01 Crab, Packaged Food (Not Commercially Sterile)
Date Published: 01/21/2010

Notes: Exempt - 5/6/2005

Viya Crab Product Co., ltd.
Date Published : 09/18/2009
75 , 2 Tambon Pumriang , Chaiya, Surat Thani THAILAND
16 J - - 01 Crab
Date Published: 01/15/2021

Desc: Canned pasteurized crabmeat
Notes: 8/23/2007 (exempt)