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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 550.700 Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - Adulteration Involving Insects; Decomposition; Dirt; Pits; and Pit Fragments

 

 

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

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;

    and
    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.

REMARKS:

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:

 

Sample Number Date of Shipment
Article Involved Dealer
Amount of Lot Shipper
Codes Analytical Conclusions

SPECIMEN CHARGE:

  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

Updated:  11/29/05