Skip page top navigation FDA Logo--links to FDA home
page Logo of and Link to start page of Office of Regulatory Affairs, 
U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

IA #16-31, ------Revised 6/7/96, Attachment A - 5/9/01, Attachment B - 5/17/02


SUBJ:     REVISION OF IMPORT ALERT #16-31, ***"DETENTION WITHOUT PHYSICAL
          EXAMINATION OF FROZEN, RAW, AND COOKED CONCHMEAT"***

NOTE:     This alert has been revised to establish a separate attachment for
          exempt firms and update the format.  Additional changes are bracketed by
          asterisks (***).

TYPE OF ALERT  :    Detention without physical examination
                    Surveillance

                    ***(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        :    Conchmeat (fresh, fresh frozen, cooked)

PRODUCT CODE   :    16E[][]06
                    16E[]A06
                    16E[]F06
                    16E[]G06
                    16E[]Y06

PROBLEM        :    Decomposition (MSDC)

PAC FOR
COLLECTION           :   03844

COUNTRIES      :    See Attachment

MANUFACTURER/
SHIPPER        :    See Attachment

MANUFACTURER/
SHIPPER ID           :   See Attachment

IMPORTER'S ID  :    N/A

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 to be otherwise unfit for food
                    [Adulteration, Section 402(a)(3)]."
RECOMMENDING
OFFICE         :    DIOP (HFC-171) and ORL-DO (HFR-SE2575)

REASON
FOR ALERT      :    This alert was initiated in 1985 for firms in the
                    Dominican Republic when it was determined that a
                    detention rate of 89.7% existed for conchmeat due to
                    decomposition.

                    In FY93, ORL-DO reported that 10 of 21 shipments
                    (47.6% detention rate) of conchmeat from firms in
                    Honduras were detained because of decomposition. Other
                    detentions were made due to presence of sulfites
                    and/or undeclared sulfites.

                    Because the handling of conchmeat, prior to the
                    cooking step, would be the same for both raw and
                    cooked conchmeat, this import alert applies to both
                    styles of product.


***GUIDANCE*** :    ***Districts may detain, without physical examination,
                    shipments of conchmeat from the firms identified on
                    Attachment A to this alert.***

                    Because of the continued high detention rate due to
                    decomposition of this product, an increase in sampling
                    and analyses of this product is warranted.

                    ***For questions or issues concerning science, science
                    policy, sample collection, analysis, preparation, or
                    analytical methodology, contact the Division of Field
                    Science at (301) 443-3320 or 3007.***

PRIORITIZATION :    II

FOI            :    No purging is required

KEYWORDS       :    Seafood, conch, conchmeat, decomposition

PREPARED BY          :   Ted Poplawski, DIOP, (301) 443-6553

DATE LOADED
INTO FIARS           :   June 7, 1996

        Attachment ***A*** to Import Alert #16-31 - 5/9/01

         Firms on detention without physical examination


DOMINICAN REPUBLIC (DO, 320)

All firms


          Attachment B to Import Alert #16-31 - 5/17/02

     Firms exempt from detention without physical examination


DOMINICAN REPUBLIC (DO, 320)



Distribuidora de Mariscos Los 7 Mares S.A.        05/17/02
Autopista 30 de Mayo Km 7 « urb
Procasa
Santo Domingo, Dominican Republic
FEI # 3001389906


Empresa Pesquera Jose A Gomez                     6/7/96
Carretera Sanchez Km9
Santo Domingo, Dominican Republic
FEI# 1000363840
MID# DOEMPPES9SAN