IA #13-01, 8/09/00


SUBJ:     IMPORT ALERT #13-01 "Detention Without Physical Examination of Ice Cream
     Products for the Presence of Listeria Monocytogenes."

(NOTE:  This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(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.)

TYPE OF ALERT  :    Detention Without Physical Examination

PRODUCT        :    Ice Cream (See Attachment)

PRODUCT CODE   :    See Attachment

PROBLEM        :    Listeria monocytogenes
                    [OASIS Charge Code=Listeria
                    Adulteration]

PAF (Problem
    Area Flag) :    MIC (Microbiological Hazard)

PAC FOR
COLLECTION          :    03819C

COUNTRY        :    N/A

MANUFACTURER
 and FEI       :    See Attachment

SHIPPER
 and FEI       :    See Attachment

CHARGE         :    The article is subject to refusal of admission
                    pursuant to section 801(a)(3) in that it appears to
                    contain Listeria, a poisonous and deleterious
                    substance which may render it injurious to health.
                    [Adulterated, 21 U.S.C. 342(a)(1)]

RECOMMENDING
OFFICE         :    FLA-DO/MIA-RP/HFR-SE2577


REASON FOR
ALERT               :    In March 2000, Florida District detained a shipment of
                         frozen fruit bars manufactured by Helados Bon CXA,
                         Santo Domingo, Republica Dominicana because analysis
                         by the Southeast Regional Laboratory detected the
                         presence of Listeria monocytogenes.

                    In December 1998, San Juan District collected a sample
                    of coconut ice cream manufactured by Helados Bon CXA
                    that was found to contain Salmonella and Listeria.  At
                    that time, although the shipment had been partially
                    distributed by the consignee, CFSAN approved a Class I
                    recall of the product.

GUIDANCE       :    Detain without physical sampling or analysis, products
                    from the manufacturer or shipper listed in the
                    attachment of this Import Alert.

                    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.

KEYWORDS       :    Helados Bon, Fruit Bars, Listeria, Ice Cream, Cxa

PRIORITIZATION
GUIDANCE       :    I

FOI            :    No purging is required.

PREPARED BY         :    Jack Geltman, Opns & Policy Br., DIOP, HFC-172,
                         (301)443-6553

DATE LOADED
INTO FIARS          :    AUGUST 9, 2000

          ATTACHMENT TO IA 13-01             8/9/00




FIRM                          PRODUCT

Helados Bon CXA                    Frozen Fruit Bars
Calle Central #1                   All product code "13"
Zona Industrial Herrera
Santo Domingo
Republica Dominicana
FEI #3002156918