Import Alert 30-02
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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 # 30-02
Published Date: 10/11/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Prune Juice Concentrate from Laparre Et Fils France"
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 firms on the Red List.
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 CFSAN/DE/HFS-605.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
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 CFSAN/DE/HFS-605.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Prune juice concentrate
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)]."
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
Countries
FRANCE
(21 K - - 15) Prunes (Dried Plums), Juice, Pit Fruit Juices or Concentrates
Problems:
LEAD;
(30 B - - 05) Beverage Base, Pit Fruit, Liquid
Problems:
LEAD;
FRANCE
P. Laparre Et Fils
Date Published : 09/18/2009
Castelnaud De Grate Cambe , CCP Toulouse 39329 , Cancon France, FRANCE
21 K - - 15 Prunes (Dried Plums), Juice, Pit Fruit Juices or Concentrates
Date Published: 09/18/2009
Desc:Prune Juice Concentrate
Problems:
LEAD;
30 B - - 05 Beverage Base, Pit Fruit, Liquid
Date Published: 09/18/2009
Desc:Prune juice concentrate
Problems:
LEAD;
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