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Import Alert 16-13

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(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 # 16-13
Published Date: 10/06/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination of Anchovy or Bagoong Products from the Philippines"

Reason for Alert:
During the six month period from November 16, 1982, through May 18, 1983, 12 out of 18 lots of anchovy products sampled and examined for filth were detained (a 67% violation rate). Ten detentions were for insect and/or rodent filth and two detentions were for E. Coli and Coliforms. Product detained included salted anchovies, anchovy sauce (bagoong), dried anchovies, and frozen anchovies. Dual declaration of the products which are subject to this action are bagoong monamon-dilis, dilis- monamon, and bagoong mabgas dilis.

Review of FY 91 detention data indicates that 41 detentions of these products were made. Further review indicated that the majority were refused due to lack of private laboratory analyses, requested refusals and physical analyses showing presence of filth. Of 8 samples collected and analyzed 15 (63%) were violative.

No detentions were noted for presence of E. Coli.

Guidance:
When entries declared as bagoong, bagoong manomon-dilis, dilis-monamon, and bagoong mabgas dilis are encountered they should be checked to determine if they are anchovy products.

Districts may detain, without physical examination, all anchovy products from the Philippines, except the packers/products identified in the Green List to this Import Alert.

When examining audit samples from entries that have been found acceptable by private laboratory results, in addition to an examination for filth, analyze for E. Coli and coliforms.

Contact the Division of Field Science at 301 796-6600 for questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
Anchovies;

Bagoong, a sauce made from anchovies or small fish which have been salted and fermented or products from Bagoong.

Charge:
"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 is otherwise unfit for food, in that it contains insect, rodent, animal or other filth" Adulteration, Section 402(a)(3)]."

AND

"This 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 is otherwise unfit for food in that it contains E.Coli/Coliforms" [Adulteration, Section 402(a)(3)]."

OASIS charge code (for both charges) - FILTHY

Countries

PHILIPPINES
(16 A - - 01) Anchovy
(16 Y - - 03) Fish Paste, Fishery Products, n.e.c.

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)



PHILIPPINES

Ayala Corporation (Mexim US)
Date Published : 09/16/2009

unlnown , Makati, Metro Manila PHILIPPINES
16 A - - 01 Anchovy
Date Published: 09/16/2009

16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 09/16/2009


MICA BY THE SEA
Date Published : 09/16/2009

Zone Ii, Bldg 19, Lanka Street , 609 Sirloin Street, FTI Complex , Taguig City, Metro Manila, Ph-Riz PHILIPPINES
16 A - - 01 Anchovy
Date Published: 09/16/2009

Notes:Exempt - 1/2/2008
16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 09/16/2009

Notes:Exempt - 1/2/2008

Rufina Patis Factory
Date Published : 09/16/2009

290 C Arellano Street , Malabon City, Metro Manila PHILIPPINES
16 A - - 01 Anchovy
Date Published: 09/16/2009

16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 09/16/2009


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