FDA WARNING_LETTER - Fruits Tress, Inc. - April 14, 2023

On April 11 and 14, 2023, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Fruits Tress, Inc. at 1401 W. Anaya Rd., Apt. 2305, Pharr, TX 78577, following a previous inspection on November 18, 2021. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found significant violations, specifically that Fruits Tress, Inc. did not develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the company failed to demonstrate that its suppliers produce food in compliance with U.S. food safety standards, including those for produce safety (21 CFR part 112). A Form FDA 483a FSVP Observations was issued on April 14, 2023, to which no response has been received.

Failure to address these violations may lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert # 99