The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) or for detaining imports.
Recommend legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for domestic samples (detain imports) if: one or more containers, analyzed by procedure outlined in LIB 1789, pages 1 through 6, is found to have a measured pH value of 4.75 or above by both the original and check analysis.
NOTE: Notify CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) immediately of all detentions.
Districts should also notify DOE if analysis of a domestic or imported sample shows: (1) one or more containers to have measured pH value of less than 4.75 but greater than or equal to 4.65; or (2) if the mean pH of the sample plus 2 standard deviations is 4.65 or above.
*Material between asterisks is new or revised.*
Revised: 3/95, 5/05
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.