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Requirement for Filing Scheduled Process

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Posted 25 May 2018 - 03:44 PM

Hello folks!


I work for co-manufacturer that, among other things, is a registered FDA canning establishment for acidified shelf stable foods. 


Is there a timeframe for filing and submitting scheduled processes for products with the FDA? Do we need to submit the process before production can occur for our clients?


Thank you!


    Food Safety Consultant, Production Supervisor

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Posted 25 May 2018 - 05:42 PM

21 CFR 108


(2) Process filing. A commercial processor engaged in the processing of acidified foods shall, not later than 60 days after registration, and before packing any new product, provide the Food and Drug Administration information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Filing of this information does not constitute approval of the information by the Food and Drug Administration, and information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). Forms are available from the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. These forms also are available on the Food and Drug Administration's Web site at http://www.fda.gov/F.../ucm2007436.htm.  For electronic submission go to FDA's Industry Systems Web site at www.access.fda.gov.


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

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Posted 04 June 2018 - 05:38 PM

What about existing Canadian companies who may wish to export to the US? Are we still required to file or is our CFIA registration sufficient, and we would be subjected to FSVA?

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