IA#05-01, -----12/22/98, Attachment, ----12/22/98
SUBJECT: IMPORT ALERT #05-01, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
INCAPARINA DUE TO AFLATOXIN"
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert represents the agency's current
guidance to FDA field personnel regarding the manufacturer
or product at issue. It does not create or confer any
rights for or on any individual and does not operate to bind
FDA or the public.)
PRODUCT: Incaparina - a mixture of maize and cottonseed flour
PRODUCT CODE: 02Y[][]99 - milled grain products, n.e.c.
05B[][]99 - cereal breakfast food, n.e.c.
40B[][]03 - infant product, high protein cereal
41B[][]99 - foods with supplemental nutrients
41E[][]99 - meal replacements
PAF: MYC (Mycotoxins)
OASIS
CHARGE CODE: AFLATOXIN
PAC FOR
COLLECTION: 07002
COUNTRY: See attachment
MANUFACTURER/
SHIPPER: See attachment
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain aflatoxin, a
poisonous or deleterious substance, which may render it
injurious to health [Adulteration, 402(a)(1)]."
RECOMMENDING
OFFICE: CFSAN/Imports Branch (HFS-606)
REASON FOR
ALERT: In March, 1998, LOS-DO and CHI-DO each collected a sample of
Incaparina for aflatoxin analysis. Results of the analysis
performed by CFSAN's Bioanalytical Chemistry Branch
indicated that the sample contained 57ppb and 163ppb of
aflatoxin respectively. These levels support the appearance
of adulteration. The current guidance for levels of
aflatoxin can be found in CPG 555.400.
The product is a mixture of corn and cottonseed flour with
added vitamins, minerals, and a preservative. It has been
marketed as a high protein food supplement particularly for
children who are not likely to consume food containing
sufficient protein.
GUIDANCE: Districts may detain, without physical sampling and
analysis, all entries of incaparina from the firms
identified on the attachment to this 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.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: Aflatoxin, Incaparina, flour, cottonseed flour, maize, corn
flour
PREPARED BY: Ted Poplawski, DIOP, (301) 443-6553.
DATE LOADED
INTO FIARS: December 22, 1998
Attachment to Import Alert# 05-01
Firms/Products Recommended for Detention Without Physical Examination (DWPE)
GUATEMALA (GT)
Alimentos, S.A. Incaparina
Km. 15 Carretera al Salvador
Apartado Postal Puerta Parada 8
Guatemala City, Guatemala
FEI #3001190781
Drafted:PatSherrod(HFS-606):9/1/98
Revised:TPoplawski:tjp:9/16/98
tjp hd\word\80880ALTB0501.DET
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