The FDA "inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety Regulation or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Based on [the] inspectional findings, [FDA] determined that [the] sprout products are adulterated."
Primary inspectional findings:
WARNING LETTER
Rhodes Legacy Inc DBA Sun Sprouts
MARCS-CMS 651402 — MAY 10, 2023
- "Failed to meet the requirement to test spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella spp. or, if such testing is not practicable, test each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for E. coli O157:H7 and Salmonella spp."
- "Did not test the spent sprout irrigation water (or sprouts) from each production batch of sprouts for Salmonella spp. using either (1) the method of analysis described in “Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, October 2015, FDA or (2) a scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity, as required by 21 CFR 112.153(a)"
- "Did not clean and sanitize food contact surfaces that you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts...investigators observed significant filth on the irrigation nozzles for your mister."
- "Did not meet the requirement that at least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum"
WARNING LETTER
Rhodes Legacy Inc DBA Sun Sprouts
MARCS-CMS 651402 — MAY 10, 2023