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 12 subsamples for the lot, or 6 subsamples for each violative code. Confirm rot microscopically by presence of mold.
The average for any code, or for the lot if no code is present, is 5% or more by count of plums with rot spots larger than the area of a circle 12 mm. in diameter.
Seizures involving these products must be discussed with the U.S. Department of Agriculture. *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
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3) in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed plums.
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005 Updated: 11/29/05
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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.