Import Alert 16-22

Import Alert # 16-22

Published Date: 09/28/2022

Type: DWPE

"Detention Without Physical Examination of Canned Shrimp from Thailand for Decomposition"

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.

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

                                                                                                                                                                        ***

Canned Shrimp

***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

Notes: Exempt - 10/16/1998

Notes: Exempt - 10/16/1998

Notes: Exempt - 5/7/1997

Notes: Exempt - 5/7/1997

Notes: Canned Shrimp Exempt - 11/9/2006

Desc: Canned Shrimp

Notes: Exempt - 11/9/2006

Desc: Minced Prawn in Spice; Commercially Sterile

Notes: Exempt - 2/7/2001

Notes: Exempt - 2/7/2001

Notes: Exempt - 2/7/2001 Office address

Notes: Exempt - 2/7/2001 Office address

Notes: Exempt - 1/14/2000

Notes: Exempt - 1/14/2000

Notes: Exempt - 7/27/1993

Notes: Exempt - 7/27/1993

Notes: Exempt - 1/25/1997

Notes: Exempt - 1/25/1997

Desc: Canned Shrimp

Notes: 7/27/1993

Desc: Canned Shrimp

Notes: 7/27/1993

Notes: Exempt - 4/22/2003

Notes: Exempt - 4/22/2003

Notes: Exempt - 5/10/2005

Notes: Exempt - 5/10/2005