Food Safety Report: FDA warning letter to Sun Sprouts.

13315 A Street, Omaha, 68106 Nebraska, United States

The FDA released a warning letter for Rhodes Legacy Inc DBA Sun Sprouts., on May 10, 2023.

The FDA inspected the sprouting operation of Rhodes Legacy Inc DBA Sun Sprouts, located at 13315 A Street, Omaha, Nebraska, from December 28, 2022, through January 6, 2023. FDA conducted this inspection because sprouts grown at this sprouting operation were linked by epidemiological and traceback evidence to an outbreak of human infections with Salmonella Typhimurium. The FDA, along with the CDC and state and local partners, investigated a multistate outbreak of Salmonella Typhimurium infections. FDA’s traceback investigation identified Sun Sprouts brand alfalfa sprouts grown by SunSprout Enterprises as a likely source of illnesses in this outbreak.

This inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation.

Produce Safety Rule Violations: During the inspection, FDA investigators observed the following significant violations of the Produce Safety regulation:

1. They 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. Specifically, they stated that they do not conduct spent sprout irrigation water testing or in-process testing for your spicy sprout blend, your broccoli sprouts or your sunflower shoots. Further, they stated they have not conducted any testing on your spicy sprout blend, your broccoli sprouts, or your sunflower shoots since April of 2022. From April 21, 2022, to December 23, 2022, they produced their spicy sprout blend times, broccoli sprouts, and sunflower shoots times. They sold these sprouts without conducting spent sprout irrigation water testing or any in-process testing.

In their written response to the FDA 483, dated January 12, 2023, they explain that they will be following a new SOP for testing sprouts grown at their facility. The SOP they provided, “SOP XX-1 Irrigation water testing for Special blends and other sprouts,” lists the following sprouts and notes that the list can change at any time: gourmet, spicy, broccoli, and sunflower. The SOP says to collect and test water sample for sprouts grown. However, They did not provide any documentation to demonstrate they have implemented and are following this procedure.

2. They 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. Specifically, on November 22, 2022, following PCR analysis, they received a presumptive positive test result for Salmonella spp. in your spent sprout irrigation water from lot 4211 of alfalfa sprouts. Neither you nor your third-party laboratory conducted a culture confirmation test on the presumptive positive sample by using a method of analysis described in the “Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, October 2015 or a scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity. Rather, they collected a new sample of spent sprout irrigation water for lot 4211 on November 22, 2022, and submitted it for analysis. Following the new sample showing a negative analysis result for Salmonella spp., they released the product for shipment into interstate commerce to their customers, including ones located in Kansas, Iowa, and Missouri. Because the samples were collected from the same production batch as the presumptive positive, that batch should be considered presumptive positive. A negative test result does not negate a previous positive test result from the same batch.

At the close of the inspection, they submitted their updated protocol on handling positive lab testing results, identified as “SOP XX. PROCEDURE FOR POSITIVE LAB,” to FDA's investigator. As written, this procedure indicates that if they receive a presumptive positive result, they will treat a presumptive positive as a true positive and, among other things, destroy all affected products, quarantine and discontinue use of the seed, notify seed suppliers, and clean and sanitize equipment. The adequacy of this corrective action will be evaluated during the next FDA inspection.

3. They did not clean and sanitize food contact surfaces that they use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts. Specifically, on January 4, 2023, FDA investigators observed significant filth on the irrigation nozzles for their mister. These nozzles are food contact surfaces used to water their sprouts growing. Water from the misters comes into contact with the harvestable portion of the sprouts that they grow. They stated the nozzles were last cleaned prior to January 4, 2023.

In their written response to the FDA 483, dated January 12, 2023, they attached a cleaning schedule for the mister nozzles (“Mister Nozzle Cleaning Schedule”). In the procedure, Mister Nozzle Cleaning Schedule, the misters would be cleaned. During the FDA inspection, They told FDA investigators that the observed filth on the misters was from of use since the previous cleaning. As the visible filth was observed on the misters after of use, this indicates that cleaning and sanitizing their mister nozzles on a quarterly basis, as identified in your written response, is not adequate to comply with the requirements of 21 CFR 112.143.

4. They did not meet the requirement that at least one supervisor or responsible party for their farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by FDA. FDA, in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health, created the Sprout Safety Alliance to help sprout producers identify and implement best practices in the safe production of sprouts. During FDA inspection, they explained to FDA investigators that neither they nor a supervisor has successfully completed at least the equivalent of the standardized curriculum, food safety training for sprouts growers (Sprouts Safety Alliance Training). Additionally, none of their employees have successfully completed at least the equivalent of the standardized curriculum, food safety training for sprouts growers (Sprouts Safety Alliance Training).

In their written response to the FDA 483, dated January 12, 2023, they stated their intention to complete part one and part two of the Sprout Safety Alliance Growers Training by the end of the calendar year. They attached their receipt for purchase of the course in your January 26, 2023, written response. The adequacy of their corrective action will be evaluated during the next inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with their products. They are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is Their responsibility to ensure that their firm complies with all requirements of federal law, including FDA regulations.

Source: www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023

About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction.".