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