REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
Actionable when the quantity of shrimp material present, based on the average of all subsamples, is less than the following percentages of the total article (as determined by the methods prescribed in the standards of identity, 21 CFR 161.175 - 161.176).
Frozen raw breaded shrimp - 45%
Frozen raw lightly breaded shrimp - 60%
Referral to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) is authorized where both the original and check analyses reveal the presence of shrimp material in amounts less than required by the standards but more than the levels stated above, provided sampling and analytical techniques are adequate to prove conclusively that the product fails to comply with the requirements of the standard. In such case, all analytical data including work sheets must be submitted along with the recommendation for action.
*Material between asterisks is new or revised*
Revised: 10/30/89, 03/95, 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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.