FDA WARNING_LETTER - Green City Distribution - March 29, 2021

On June 30, 2021, the FDA issued a Warning Letter to Green City Distribution following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from March 25-29, 2021. This inspection, the third since November 2018, found the company non-compliant with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The primary violation was the failure to develop, maintain, and follow an FSVP for any imported foods, including broad beans from two foreign suppliers, kidney beans, and coconut fudge. Additionally, for low-acid canned foods like broad beans and kidney beans, the company failed to verify and document that these products were produced in accordance with 21 CFR Part 113, as required by 21 CFR 1.502(b)(1).

The FDA noted the company's April 7, 2021, email response stating a plan to obtain an FSVP within seven months, but highlighted that this was the third inspection revealing the same deficiencies. Failure to adequately address these violations may result in refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz). Green