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U.S. Department of Health and Human Services

Import Alert 24-17
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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 # 24-17
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Canned Jalapeno Peppers from Transcafe Int'l S.A. Costa Rica Because of Botulism"

Reason for Alert:
New Orleans District sampled a shipment of #10 cans of jalapeno peppers, halves, after a field exam found abnormal cans. Atlanta Regional Lab analyses of the sample revealed pH levels greater than 4.6 and swollen cans. One can was found to contain preformed C. botulinum toxin, Type A, using BAM, 7th Edition (1992), Chapter 17, (confirmed by CFSAN). This product is considered to be a potentially life-threatening acute health hazard because of the presence of C. botulinum toxin.

This firm/product is also subject to detention without physical examination under Import Alert #99-04, "Detention Without Physical Examination of Manufacturers of Low-Acid Canned Foods." This separate alert is needed to prevent this firm/product from being overlooked within the long list (approx. 440 firms/thousands of products) currently in Import Alert #99-04.

Guidance:
Disctricts may detain, without physical examination, all canned peppers and any other LACF/ALACF products manufactured by Transcafe International S.A., San Jose, Costa Rica. Private lab test results would not be sufficient to remove the appearance of a violation. Therefore, shipments must not be released until satisfactory corrective actions are documented and have the concurrence of CFSAN.

Product Description:
Canned Jalapeno Peppers

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(1) and (a)(3) in that it appears to bear or contain a poisonous or deleterious substance, C. botulinum toxin, in such a quantity that ordinarily renders it injurious to health [Adulteration, Section 402(a)(1)]."

OASIS charge code - POISONOUS

and

"...to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]."

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


COSTA RICA
Transcafe International SA
Date Published : 09/16/2009

PO Box 505 , Zapote , San Jose, COSTA RICA

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