Import Alert 16-31

Import Alert # 16-31

Published Date: 02/25/2022

Type: DWPE

"Detention Without Physical Examination of Frozen Raw and Cooked Conchmeat"

This alert was initiated in 1985 for firms in the Dominican Republic when it was determined that a detention rate of 89.7% existed for conchmeat due to decomposition.

In FY93, ORL-DO reported that 10 of 21 shipments (47.6% detention rate) of conchmeat from firms in Honduras were detained because of decomposition. Other detentions were made due to presence of sulfites
and/or undeclared sulfites.

Because the handling of conchmeat, prior to the cooking step, would be the same for both raw and cooked conchmeat, this import alert applies to both styles of product.

Divisions may detain, without physical examination, all shipments of conchmeat that are from firms not in the attachment for this alert.


Because of the continued high detention rate due to decomposition of this product, an increase in sampling and analyses of this product is warranted.

*** In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer (or owner, consignee and/or another responsible party to the shipment) should provide:

Results of a third-party laboratory analysis, of a representative sample of the lot, (of a representative sample of the detained product) which verifies that the product does not contain odors of decomposition.

Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the Notice of FDA Action (Notice of Detention).
Third-party laboratories may use any methods that are found acceptable to FDA.

SAMPLED IMPORTED PRODUCTS MUST BE HELD PENDING THE ANALYSIS RESULTS IN ACCORDANCE WITH 21 CFR 1.90

All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA ORA Lab Manual, volume III, section 7 https://www.fda.gov/media/73540/download. 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 (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates 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 detention without physical examination 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 private laboratory analyses.

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)" https://www.fda.gov/media/71776/download.

If a firm and/or a representative thereof would like to request removal from detention without physical examination 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 detention without physical examination will be reviewed by DIO.

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 on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov ***

                                                                                                                                                     

Frozen raw and cooked conchmeat

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

OASIS charge code - FILTHY

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996