IA #37-05 - 6/22/99, IMPORT ALERT #37-05 "Detention Without Physical
Examination Of Heat and Serve Products Containing Cheese For the Presence of
Listeria moncytogenes", Attachment - 1/14/08
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: ***All heat and serve products containing cheese
PRODUCT CODE: See Attachment
PROBLEM: Listeria moncytogenes
PAF (Problem
Area Flag): MIC (Microbiological Hazard)
PAC FOR
COLLECTION: 03819C
COUNTRY: ***See Attachment
MANUFACTURER: See Attachment
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)]
(OASIS Charge code: Listeria)
RECOMMENDING
OFFICE: DAL-DO, HFR-SW155/DIOP, HFC-170
LOS-DO, HFR-PA256/DIOP, HFC-170
REASON FOR
ALERT : In October 1998, Dallas District detained two separate
shipments (cheese flautas and cheese corn dobladitas) from
Sigma Alimentos Congelados, Linares, N.L., Mexico, due to the
presence of Listeria monocytogenes. Subsequently, this firm
submitted acceptable private laboratory analysis for the
cheese flautas and this product is not subject to DWPE.
Districts however, should sample this product on a
surveillance basis.
***In February 2003, Seattle District detained an entry of
heat and serve bacon, egg and cheese pastries from Canada
contaminated with L. monocytogenes.
GUIDANCE: Detain without physical sampling or analysis products from
the manufacturers and shippers listed in the attachment of
this alert. Increased surveillance of other similar products
from these and other manufacturers appears warranted.
When districts encounter shipments of products found to be
violative for Listeria monocytogenes, a recommendation for
detention without physical examination and background
information, including analytical worksheets and labels with
cooking instructions, should be forwarded to DIOP, HFC-170.
DIOP will coordinate with CFSAN for concurrence.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at
(301)827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required.
PREPARED BY: ***Linda Wisniowski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: April 4, 2003
ATTACHMENT TO IMPORT ALERT #37-05 1/14/08
CANADA (CA)
Hygaard Fine Foods Ltd. Little John Sub
208 Sioux Rd. 37S[][]40
Sherwood Park 11/3/03
Alberta T8A3X5
Canada
FEI #3001097272
Les Plats Du Chef, Inc. Bacon, egg and cheese pastries
51 Rue Keesmark 37S[][]01, 37S[][]30, 37S[][]40
Dollard-Des-Ormeaux, 4/4/03
Quebec, H9B 3J1, Canada
FEI #3003292406
FRANCE (FR)
Frial S.A. Egg Plant and Goat
Saint Martin Des Entrees Cheese Sautee
BP 60090 12Y[][]99
14401 Bayeux 24K[][]01
France 37B[][]99
FEI# 3003774310 1/14/08
MEXICO (MX)
Sigma Alimentos Congelados, S.A.
Av. Industrial Alimenticia 760 Cheese Corn Dobladita
Linares, Nuevo Laredo 37C[][]20
Mexico ***6/22/99
FEI #3000998734
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