Import Alert 16-22
(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 # 16-22
Published Date: 09/28/2022
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Canned Shrimp from Thailand for Decomposition"
Reason for Alert:
NOTE: The revision of this Import Alert (IA) dated 09/27/2022 updates the guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***).
This import alert issued in 1981 based on an 85% detention rate due to decomposition. Review of the detention data for FY91-92 indicated decomposition in canned shrimp continues to be a problem. Of 21 detentions made in FY91, 6 resulted in refusals (29%) due to decomposition. Of 8 detentions made in FY92, 4 (50%) resulted in refusals due to decomposition.
This import alert issued in 1981 based on an 85% detention rate due to decomposition. Review of the detention data for FY91-92 indicated decomposition in canned shrimp continues to be a problem. Of 21 detentions made in FY91, 6 resulted in refusals (29%) due to decomposition. Of 8 detentions made in FY92, 4 (50%) resulted in refusals due to decomposition.
Guidance:
Divisions may detain without physical examination all canned shrimp from Thailand except shipments from the packers identified on the attachment to this import alert.
Detention without physical examination (DWPE) is not intended to apply to shrimp products manufactured from dried shrimp/prawns. Such products are generally in the form of a sauce or paste; label and/or physical examination may be necessary to verify claims that a particular product was manufactured from dried shrimp/prawns. For product which appears to be manufactured from dried shrimp/prawns but does not contain a statement of identity indicating dried shrimp/prawn, please contact Division of Enforcement/Labeling Compliance Team at ***CFSAN-OC-LDSCBInquiries@fda.hhs.gov ***
***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, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product is not decomposed. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical 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, 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.*** 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). FDA recommends a firm requesting removal from DWPE provide the following information:
1. Results of the firm's investigation(s) into the problem (i.e. failure to prevent contamination with decomposition)
2. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum:
A description of current manufacturing processes; and
Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on non-violative private laboratory analyses and corrected product labels of shipments.
For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)" https://www.fda.gov/media/71776/download
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be forward 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
Requests for removal from DWPE will be reviewed by DIO.
*** Questions or issues involving import operations should be addressed to the Division of Import Operations 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 other 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
***
Detention without physical examination (DWPE) is not intended to apply to shrimp products manufactured from dried shrimp/prawns. Such products are generally in the form of a sauce or paste; label and/or physical examination may be necessary to verify claims that a particular product was manufactured from dried shrimp/prawns. For product which appears to be manufactured from dried shrimp/prawns but does not contain a statement of identity indicating dried shrimp/prawn, please contact Division of Enforcement/Labeling Compliance Team at ***CFSAN-OC-LDSCBInquiries@fda.hhs.gov ***
***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, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product is not decomposed. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical 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, 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.*** 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). FDA recommends a firm requesting removal from DWPE provide the following information:
1. Results of the firm's investigation(s) into the problem (i.e. failure to prevent contamination with decomposition)
2. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum:
A description of current manufacturing processes; and
Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on non-violative private laboratory analyses and corrected product labels of shipments.
For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)" https://www.fda.gov/media/71776/download
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be forward 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
Requests for removal from DWPE will be reviewed by DIO.
*** Questions or issues involving import operations should be addressed to the Division of Import Operations 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 other 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:
Canned Shrimp
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
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 - E 05) Shrimp & Prawns, Commercially Sterile
-
(16 J - I 05) Shrimp & Prawns, 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
Continental Pacific Corp., Ltd.
Date Published : 09/18/2009
136/1 Naklua Road
, Pattani,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
Notes: Exempt - 10/16/1998
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 10/16/1998
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 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
Notes: Exempt - 5/7/1997
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 5/7/1997
Kingfisher Holdings Ltd
Date Published : 09/18/2009
24, 26 RAJ-U-THID 1 ROAD, , TAMBOL BO-YANG,
, AMPHUR MUEANG SONGKHLA,
SONGKHLA THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
MMP International Co. Ltd.
Date Published : 09/18/2009
19/8 Moo 6 Tambol Nadee
, Mueang Samut Sakhon,
Samut Sakhon THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
Notes: Canned Shrimp
Exempt - 11/9/2006
16 X - E 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Commercially Sterile
Date Published: 06/22/2022
Desc: Canned Shrimp
Notes: Exempt - 11/9/2006
N R Instant Produce Co Ltd
Date Published : 03/04/2022
75 Thanon Ko Mo Soi 12
, Krathum Baen,
Samut Sakhon THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 03/04/2022
Desc: Minced Prawn in Spice; Commercially Sterile
Pan Asia (1981) Co., Ltd.
Date Published : 09/18/2009
Takarm District, Punpin , 17 Charoenlarp Road
, Suratthani,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
Notes: Exempt - 2/7/2001
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 2/7/2001
Pan Asia (1981) Co. Ltd.
Date Published : 09/18/2009
814 Sukhumvit 103
, Prawet,
Bangkok THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
Notes: Exempt - 2/7/2001
Office address
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 2/7/2001
Office address
Pan Asia Food Industry Co Ltd (factory)
Date Published : 09/18/2009
21/3 Talad Lang Tambol , Bangkung
, Suratthani,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Pataya Food Industries Limited
Date Published : 09/18/2009
90/6 Moo 7, Settakit 1 Road
, Muang Samut Sakhon,
Samutsakhon THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
Notes: Exempt - 1/14/2000
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 1/14/2000
Product Canned Fish Siam Co
Date Published : 09/18/2009
224 Yontrakarnkarntorn
, Stoon,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
Notes: Exempt - 7/27/1993
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 7/27/1993
Samui Foods Co., Ltd.
Date Published : 09/18/2009
T. Makamitia , 15/1 Moo, 6 Bandon-Nasan Road
, Suratthani,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
Notes: Exempt - 1/25/1997
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 1/25/1997
Siam Tin Food Product Co., Ltd.
Date Published : 06/22/2022
224 Yontakankumton Road
, Muang Satun,
Satun THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 06/22/2022
Desc: Canned Shrimp
Notes: 7/27/1993
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 06/22/2022
Desc: Canned Shrimp
Notes: 7/27/1993
Thai Cannery Co Ltd
Date Published : 09/18/2009
90/6 Mu 7 Thasai, Muang
, Samutsakorn,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Thai Union Manufacturing Co., Ltd.
Date Published : 09/18/2009
94 5 Chumchon Setthakit 2 Alley
, Mueang Samut Sakhon,
Samut Sakhon THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
The Peace Canning Co., Ltd.
Date Published : 09/18/2009
Maefakmai Sansai , 88 Moo 5 Sansai - Prao Road
, Chieng Mai,
THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 01/20/2010
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Tropical Canning (Thailand) Public Company
Date Published : 09/18/2009
1 , 2 Thungdon Alley
, Hat Yai,
Songkhla THAILAND
16 J - E 05 Shrimp & Prawns, Commercially Sterile
Date Published: 09/18/2009
Notes: Exempt - 4/22/2003
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 09/18/2009
Notes: Exempt - 4/22/2003
V. Thai Food Product Co., Ltd.
Date Published : 09/18/2009
Bangplakod , 221 Moo 1 Suk Sawat Rd
, Phra Samut Chedi,
Samut Prakan THAILAND
16 J - I 05 Shrimp & Prawns, Acidified
Date Published: 01/20/2010
Notes: Exempt - 5/10/2005
16 J - - 05 Shrimp & Prawns
Date Published: 09/18/2009
Notes: Exempt - 5/10/2005