FDA WARNING_LETTER - ZEST US WHOLESALE INC. - June 03, 2025

On June 3, 2025, the FDA issued a Warning Letter to Zest US Wholesale Inc. following an April 28, 2025, inspection regarding compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L) and section 805 of the FD&C Act. The inspection revealed significant violations, specifically that Zest US Wholesale Inc. did not develop, maintain, and follow an FSVP for any imported foods, including Milk Chocolate Bar with Peanuts, Pistachio Spread Cream, and Coconut Almond Truffle. A Form FDA 483a, FSVP Observations, was issued, and no response has been received.

Additionally, the facility at 1139 Patt Street, Anaheim, CA 92801, is subject to food facility registration requirements under section 415 of the FD&C Act (21 U.S.C. 350d) and 21 CFR part 1, subpart H, but FDA records indicate non-compliance with this requirement.

The FDA warns that failure to adequately address these violations may result in further action, including refusal of admission of imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(