FDA WARNING_LETTER - Sky Global Food Inc - December 23, 2020

On December 22 and 23, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Sky Global Food, Inc., following a previous inspection on September 6, 2018. The inspection aimed to determine compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which require importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The inspection revealed significant violations, specifically that Sky Global Food, Inc. did not develop, maintain, or follow an FSVP for any imported foods, including Dried Red Chili Pepper Powder, Wheat Noodle, and Dried Eggplant. This non-compliance violates section 805 of the FD&C Act and 21 CFR 1.502(a). The firm was issued Form FDA 483a, FSVP Observations, on December 23, 2020, but no response has been received.

Failure to address these violations may lead to regulatory action, including refusal of admission for imported 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) of the FD&C Act. Sky Global Food, Inc. must respond