FDA WARNING_LETTER - Global Imports Inc. - January 05, 2022

On April 7, 2022, the FDA issued a Warning Letter to Global Imports Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted from December 15, 2021 – January 5, 2022, and previously from June 16, 2021 – July 21, 2021. The inspections determined non-compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which mandate risk-based activities for imported human and animal food to meet U.S. food safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for imported food products, including Chopped Spinach, Cut Cauliflower, Cut Corn, and Diced Yellow Peaches. A Form FDA 483a FSVP Observations was issued on January 26, 2022, to which no response was received.

The FDA stated that failure to adequately address these violations could result in refusal of admission of imported food under section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert # 99-41, and prohibition of importation under section 3