REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
NOTE: Examine a minimum of ten subsamples.
1. Dried and Dehydrated Low Moisture Prunes - The average of the subsamples is 5 percent or more by count insect infested, moldy or decomposed, dirty and/or otherwise unfit prunes.
2. Pitted Prunes - Examination of a minimum of 50 prunes from each of 10 subs from each code, or from the lot if no codes are present, by microanalytical manual method M13K3 shows the following:
An average of 2% or more by count of prunes with whole pits and/or pit fragments 2mm or longer;
Four or more of the 10 subs examined contain 2% or more prunes by count with whole pits and/or pit fragments 2 mm or longer.
Seizures of these products must be discussed with U.S.D.A. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Amount of Lot
Date of Shipment
1. Filth adulteration - Article adulterated when introduced into and while in interstate commerce, within the meaning of U.S.C. 342(a)(3) in that it consists wholly or in part of a filthy substance by reason of presence therein of insects, insect webbing, insect excreta, insect damaged prunes and dirt; and of a decomposed substance by reason of presence therein of moldy, decomposed prunes.
2. Pitted Prunes - Article adulterated when introduced into and while in interstate commerce, within the meaning of U.S.C. 342(b)(2) in that prunes with pits and/or pit fragments have been substituted wholly or in part for pitted prunes.
Article misbranded when introduced into and while in interstate commerce, within meaning of *21 U.S.C. 343(a)(1)* in that label statement "Pitted Prunes" is false and misleading as applied to a product containing prunes with pit fragments.
Issued: 10/1/80 Revised: 3/95, 5/2005
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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