FDA WARNING_LETTER - Jack & The Green Sprouts, Inc. - October 21, 2024

The FDA issued a Warning Letter to N8477 770th St., River Falls, WI, following an inspection from October 9-21, 2024. The inspection revealed significant violations of the Produce Safety Rule (21 CFR Part 112), rendering the firm's sprouts adulterated under 21 U.S.C. § 342(a)(4). Additionally, analytical results from September 2024, October 2024, and January 2025 confirmed the presence of Listeria monocytogenes in sprouts, leading to adulteration under 21 U.S.C. § 342(a)(1). The firm initiated multiple recalls in response to these findings. Key deficiencies included an inadequate environmental monitoring plan lacking sufficient sampling sites to effectively detect Listeria species, as required by 21 CFR 112.145(c)(3). Investigators also observed unclean and unsanitary food contact surfaces, and a failure to use equipment designed for adequate cleaning (21 CFR 112.123(a)). Furthermore, significant rodent activity was noted, indicating a failure to protect produce and food contact surfaces from pest contamination (21 CFR 112.128(a)) and to exclude pests from enclosed buildings (21 CFR 112.128(b)). The firm had not responded to the initial FDA 483. The FDA requires a written response within 15 working days detailing specific corrective actions, recurrence prevention, and supporting documentation, warning that failure to comply may result in legal action, including seizure and injunction.