California Terra Garden Inc. – FDA Warning Letter, Jun 8, 2021

The FDA issued a Warning Letter to California Terra Garden Inc. following a Foreign Supplier Verification Program (FSVP) inspection from May 11 to June 8, 2021, prompted by *Listeria monocytogenes* findings in imported enoki and seafood mushrooms, leading to recalls. The inspection found the company non-compliant with 21 CFR part 1 subpart L for fresh enoki, king oyster, and fresh seafood mushrooms from specific foreign suppliers.

Violations include failure to approve foreign suppliers based on proper evaluation of their performance and food risk, specifically not considering suppliers' procedures related to food safety or compliance with the Produce Safety Rule (21 CFR Part 112). The company's June 22, 2021, response was deemed inadequate as it lacked details on how suppliers would meet the Produce Safety Rule or information on other imported produce.

Additionally, supplier verification activities did not adequately assure that hazards were minimized, failing to verify supplier compliance with the Produce Safety Rule. The company's response regarding certifications (Quality Management System, HACCP) and plans for GLOBAL GAP and testing lacked sufficient detail or English translations for evaluation.

The FDA stated that failure to address these violations could lead to refusal of admission for imported mushrooms under section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE). The letter also noted the company's inability to conduct onsite audits due