Import Alert 16-23

Import Alert # 16-23

Published Date: 03/01/2023

Type: DWPE

"Detention Without Physical Examination of Fresh and Fresh Frozen Lobster/Lobster Tails from India"

Note: The revision of this Import Alert (IA) dated 03/1/2023 updates the reason for alert, guidance section including agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***).

From October 1, 1982, through March 31, 1983, FDA detained 14 of 32 entries of fresh/frozen lobster/lobster tails from India examined for decomposition (44% violation rate). Twelve of the detentions were solely for decomposition. Two were for both salmonella and decomposition.

FY 91 detention data shows five detentions representing five different firms in India. Review of sample collections and analyses data for FY 91 revealed that 13 had been collected with 4 violations for decomposition (31%). Also, two of the four violative samples were from firms in the green list (Castlerock Seafoods and Sawant Food Products).

***An evaluation of importation history from 2013-2022, indicates that processors of fresh and frozen lobster/lobster tails from India have not identified and corrected the problem.

Salmonella should not be overlooked as a possible problem area. ***

Divisions may detain without physical examination, all fresh/frozen lobster tails from India, except those firms on the Green List.

***A single violative sample may be sufficient evidence to remove a firm from the Green List of this alert (subject to DWPE).

Recommendations for removal from the Green List should be sent to DIO and forwarded to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation on a case by case basis.***

***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 does not contain decomposition. Such evidence could include Private laboratory analysis of a representative sample(s) collected from the affected article.

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 remove a firm's product from DWPE, information should be provided to FDA 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 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) A description of current manufacturing processes; and

B) 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

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 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

                                                                                                                                                               ***

Fresh or Frozen Lobster/Lobster Tails

***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