IA #16-121 - 8/17/04 - REVISION OF IMPORT ALERT #16-121, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF ***PROCESSED*** SEAFOOD PRODUCTS DUE TO E.COLI",
ATTACHMENT 4/19/05
NOTE: This revision changes the name of the alert and adds a firm
and product to the attachment which lists firms and products
subject to detention without physical examination. Changes
are bracketed by asterisks (***)
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert contains guidance to FDA field personnel
only. It does not establish any requirements, or create any
rights or obligations on FDA or on regulated entities.
PRODUCT: *** Processed *** Seafood Products
PRODUCT
CODE: 16[][][][] (as identified on attachment)
PAC FOR
COLLECTION: 03844
PAF FOR
COLLECTION: MIC (Microbiological contamination)
COUNTRY: See attachment
MANUFACTURER: See attachment
MANUFACTURER/
I.D.#: See attachment
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain excessive
levels of E. coli indicative that it has been prepared,
packed, or held under insanitary conditions whereby it may
have become contaminated with E. coli, whereby it may have
been rendered injurious to health" [Adulteration, Section
402(a)(4)]."
RECOMMENDING
OFFICE: Division of Import Operations & Policy, HFC-170 NYK - Import
Branch (HFR-NE152)
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.
GUIDANCE: Districts may detain without physical examination
***products*** from the ***manufacturers*** identified in
the attachment to 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).
For questions or issues concerning science, science policy,
sample analysis, preparation or analytical methodology
contact the Division of Field Science at (301) ***827-7605
or 7606***.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required.
KEYWORDS: E. Coli, ***Processed Seafood Products***
PREPARED BY: Doug Randes, SDWG, DIOP, HFC-172, 301-443-6553
DATE LOADED
INTO FIARS: August 17, 2004
ATTACHMENT TO IMPORT ALERT #16-121 4/19/05
LIST OF MANUFACTURERS/SHIPPERS ON DETENTION WITHOUT PHYSICAL EXAMINATION
HONG KONG (HK)
FIRM PRODUCT
Sun Wah Marine Products Fzn. Cooked
Tuen Mun Clam Meat
Hong Kong 16E[][]02
FEI# 1000154306
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