FDA WARNING_LETTER - rhodes legacy inc - January 06, 2023

On May 10, 2023, the FDA issued a Warning Letter to SunSprout Enterprises following an inspection from December 28, 2022, to January 6, 2023. The inspection was prompted by epidemiological and traceback evidence linking the company's sprouts to a Salmonella Typhimurium outbreak.

The inspection revealed serious violations of the Produce Safety Regulation (21 CFR Part 112), leading to the determination that SunSprout's products are adulterated under 21 U.S.C. § 342(a)(4). Key violations include:

1. **Failure to Test Spent Sprout Irrigation Water/In-Process Sprouts:** The company did not test spent sprout irrigation water or in-process sprouts for E. coli O157:H7 and Salmonella spp. for spicy sprout blend, broccoli sprouts, or sunflower shoots, as required by 21 CFR 112.144(b) and 112.147. No documentation was provided to show implementation of their new SOP for testing.

2. **Improper Handling of Presumptive Positive Test Results:** On November 22, 2022, a presumptive positive result for Salmonella spp. in alfalfa sprout irrigation water (lot 4211) was not culture-confirmed as required by 21 CFR 112.