Marquis Worldwide Specialty, Inc. – FDA Warning Letter, Jun 10, 2021

On October 29, 2021, the FDA issued a Warning Letter to Marquis Worldwide Specialty, Inc. following a Foreign Supplier Verification Program (FSVP) inspection from June 8-10, 2021. The inspection was prompted by a recall of imported Organic Enoki Mushroom products, which tested positive for *Listeria monocytogenes*.

The company was found in violation of 21 CFR Part 1 Subpart L and Section 805 of the FD&C Act for imported organic enoki and king oyster mushrooms. Key violations include:

1. **Failure to develop and follow an adequate FSVP (21 CFR 1.502(a)):** The company's FSVP did not ensure foreign suppliers complied with the Produce Safety Rule (21 CFR 112) for "covered produce." Hazard analyses for both mushroom types failed to consider the Produce Safety Rule, growing/harvesting processes, or identify *Listeria monocytogenes* as a biological hazard. Verification activities did not consider applicable FDA food safety regulations.

2. **Failure to modify FSVP after becoming aware of non-compliance (21 CFR 1.508(b)):** Despite FDA samples confirming *Listeria monocytogenes* contamination in imported enoki mushrooms, leading to the foreign supplier being placed on Import Alert #99-23, the company did not provide documentation of a revised and