DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED OR PICKLED FINFISH FROM THAILAND

NOTE: Revision to this Import Alert dated June 28, 2012 contains minor editorial corrections and updated sampling instructions. Changes noted and bracketed by three asterisks (***).

During the six month period from October 27, 1982, through April 27, 1983, 10 out of 16 samples of pickled fish from Thailand were detained (a 62% detention rate) for insect and rodent filth.

During the six month period from September 1, 1984, through February 28, 1985, 13 out of 24 samples of dried fish from Thailand were detained (a 54% detention rate) for insect, rodent, bird and/or cat filth, in addition to mold, decomposition, and violative labeling.

Districts may detain, without physical examination, all shipments of dried or pickled finfish from Thailand, except those listed on the attachment to this alert.

This detention without physical examination does not cover other dried marine products such as dried shrimp. It does, however, cover fish preserved by other methods which include essentially the same ingredients as pickled fish.

***In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the responsible party for the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. The evidence submitted should demonstrate compliance of the article in that the product does not appear to contain unacceptable levels of filth.

The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation:

1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses;
2. Each sample should consist of 10 subsamples, containing one pound (1 lb.) per subsample;
or,
10 subsamples per lot of consumer sized packages containing up to one pound (1 lb.);

or;

For consumer sized packaging in excess of one pound (1 lb.) or other unique sample collection situations, please contact CFSAN for further guidance.

Proper sampling and analytical records should be submitted to the appropriate FDA District compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference 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.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, ¿Detention Without Physical Examination (DWPE).¿

If a firm wishes to petition FDA to be added to the Green List of this Import Alert, all relevant information supporting the request should be forward to the following address:

Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

For questions or issues involving import operations, contact the Division of Import Operations & Policy at (301) 796-0356.

For questions or issues concerning preparation of sample for analysis or analytical methodology, contact the Division of Field Science at (301) 796-6600.

For questions on policy or sample collection recommendations, contact the Office of Compliance, Division of Enforcement, CFSAN at (240) 402-1750 or via email at: CFSANEnforcement@fda.hhs.gov

***

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)




Currently, no firms are exempt under this Import Alert.

Dried or Pickled Finfish

PROBLEM:
Filth

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain rodent, insect, bird and/or cat filth [Adulteration, Section 402(a)(3)]."

OASIS charge code - FILTHY