IA #30-02, REVISED 10/3/96, IMPORT ALERT #30-02, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF PRUNE JUICE CONCENTRATE FROM LAPARRE
ET FILS, FRANCE"
NOTE: This alert is being revised to reflect updated information. Additional
changes are bracketed by asterisks(***).
TYPE OF ALERT: Detention without physical examination
(Note: This import alert contains guidance to FDA field personnel
only. It does not establish any requirements, or create any
rights for, or obligations on, FDA or regulated entities.)
PRODUCT : Prune juice concentrate
PRODUCT CODE : 21K[][]15
***30B[][]05***
PROBLEM : Excessive levels of lead (HMPB)
PAC FOR
COLLECTION : 04016B
COUNTRY : France (350, FR)
SHIPPER : LaParre Et Fils
Castelnaud De Grate Cambe
47290 Cancon, France
MID# 1000250658
FEI# FRLAPETCAN
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous or
deleterious substance, lead, which may render it injurious to
health [Adulteration, Section 402(a)(1)]."
RECOMMENDING
OFFICE : CFSAN\DOE\Import Branch, HFS-606
REASON FOR
ALERT : As a result of a lead finding in apple-prune baby juice
analyzed under the Total Diet Study Compliance Program, KAN-DO
performed analysis of prune juice concentrate used to
manufacture the baby juice. The concentrate was found to
contain approximately 1.50 parts per million lead. Follow-up
investigations traced the source of the prune juice
concentrate to a French shipper, LaParre.
GUIDANCE : Districts may detain without physical sampling
or analysis, prune juice concentrate from the above firm.
Increased sampling of ***other*** prune juices and
concentrates, as well as beverages found to contain prune
juice or concentrate as ingredients is warranted. Findings of
0.30 ppm and above for concentrates, or 0.08 ppm and above for
single strength juices, should be brought to the attention of
David Egelhofer, CFSAN/DOE/HFS-606, 202-205-4606, for
discussion of possible regulatory action.
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 : lead, prune, juice, concentrate, LaParre
PREPARED BY : Jack Geltman, DIOP, (301) 443-6553.
DATE LOADED
INTO FIARS : October 3, 1996
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