Import Alert 16-121
(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 # 16-121
Published Date: 01/12/2018
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Processed Seafood Products Due to E. Coli"
Reason for Alert:
New York Import Branch collected a sample of frozen cooked clam meat. Analysis by the Northeast Regional Laboratory revealed excessive levels of E. coli.
The Center for Food Safety and Applied Nutrition is prepared to support detention without physical examination in instances where excessively high levels of E. coli are found. These levels are an indication that the product has been processed under insanitary conditions thereby creating a potential threat to the health of consumers. This meets the criteria established in the August 1995 issue of the Regulatory Procedures Manual (RPM), Chapter 9, Subchapter - Automatic Detention, Recommendations Based on One Violative Sample, Item 1, namely, that consumption of this product may have adverse health consequences to consumers, warranting a class 1 or class 2 recall.
The Center for Food Safety and Applied Nutrition is prepared to support detention without physical examination in instances where excessively high levels of E. coli are found. These levels are an indication that the product has been processed under insanitary conditions thereby creating a potential threat to the health of consumers. This meets the criteria established in the August 1995 issue of the Regulatory Procedures Manual (RPM), Chapter 9, Subchapter - Automatic Detention, Recommendations Based on One Violative Sample, Item 1, namely, that consumption of this product may have adverse health consequences to consumers, warranting a class 1 or class 2 recall.
Guidance:
Districts may detain, without physical examination, products from the manufacturers identified in the attachment for this alert. Sampling of shipments of processed seafood products from other processors may be appropriate.
For guidance concerning sample collection, sample sizes, sample preparation, analytical methodology, and regulatory follow-up, refer to the Import Seafood Products Compliance Program (7303.844).
Contact the Division of Field Science at 301 796-6600 for questions or issues concerning science, science policy, sample analysis, preparation or analytical methodology.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
For guidance concerning sample collection, sample sizes, sample preparation, analytical methodology, and regulatory follow-up, refer to the Import Seafood Products Compliance Program (7303.844).
Contact the Division of Field Science at 301 796-6600 for questions or issues concerning science, science policy, sample analysis, preparation or analytical methodology.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Procesed seafood products
Charge:
"The article is subject to refusal of admission pursuant Section 801(a)(3) in that it article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)].
OASIS charge code - INSANITARY
OASIS charge code - INSANITARY
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
HONG KONG
Sun Wah Marine Products Far East Co Ltd/ Sun Wah Cold Storag
Date Published : 09/16/2009
215-239 Wu Shan Rd Sun Wah Coldstorage , Tuen Mun Town Lot 274 Area 44
, Tuen Mun,
N T HONG KONG
16 E - - 02 Clams
Date Published: 09/16/2009
Problems:
ESCHERICHIA : COLI (TYPICAL);
VIETNAM
THANH AN CO., LTD.
Date Published : 09/16/2009
Lot 2, Street # 2, , Song Than 1 Industrial Park,
, Di An District,
VN-57 VIETNAM
16 E - - 02 Clams
Date Published: 09/16/2009
Desc:Frozen; Cooked
Notes:DWPE date - 1/7/2009
Problems:
ESCHERICHIA : COLI (TYPICAL);