There have been a number of detentions of low-acid canned foods because the foreign manufacturer failed to register and/or file process information. There have also been a number of subsequent inquiries concerning the status of these detained products after the manufacturer has filed his process information with FDA.
Since FDA inspections to establish the compliance of foreign firms are not always feasible, the Center for Food Safety and Applied Nutrition considers the submission of process information to be a significant means of appraising the public health significance of processes used for foreign firms. These submissions are given a cursory review to determine whether there are any obvious questions regarding the adequacy of the process and are edited to be put into the computer for detailed review, by product category, later.
Low-acid canned foods which are detained for reasons such as failure to register or file processes are in violation of Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that they are adulterated within the meaning of Section 402(a)(3) or 402(a)(4), whichever is appropriate. These products may be released from detention if the firm subsequently submits adequate registration and/or process information as judged by the Center for Food Safety and Applied Nutrition. Refer to current Low-Acid Canned Foods Compliance Programs for complete instructions.
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.