The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
The sample shows an average (48 units examined) short weight of one percent or more.
Shrinkage, or other loss in weight due to storage or shipping conditions, and variations in tare weights have been ruled out as factors contributing significantly to the apparent shortage.
*Material between asterisks is new or revised.*
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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.