FDA WARNING_LETTER - Rainfield Marketing Group, Inc. - June 15, 2021

On November 3, 2021, the FDA issued a Warning Letter to Rainfield Marketing Group, Inc. following a June 15, 2021, Foreign Supplier Verification Programs (FSVP) inspection. The inspection was prompted by the detection of *Listeria monocytogenes* in enoki mushrooms imported by Rainfield, leading to a voluntary recall and Import Alert #99-21.

The inspection revealed significant violations of 21 CFR Part 1, Subpart L, for imported enoki mushrooms, king oyster mushrooms, and spinach from Korea, and other products. Rainfield Marketing Group, Inc. failed to develop, maintain, and follow FSVPs for multiple imported foods, including perilla leaves, strawberries, garlic bulb, grapes, and cilantro.

Additionally, the company's onsite audits of foreign suppliers for enoki mushrooms, king oyster mushrooms, and spinach did not adequately consider applicable FDA food safety regulations, specifically the Produce Safety Rule (21 CFR 112.3). While the company provided GAP/Primus certifications, they did not demonstrate that the suppliers' processes provided the same level of public health protection as FDA regulations.

Furthermore, Rainfield Marketing Group, Inc. failed to retain complete documentation for sampling and testing of foods, lacking details on the number of samples tested, analytical methods used, and qualifications of testing personnel.

The FDA requires a written response within fifteen working days detailing corrective actions, including