FDA WARNING_LETTER - GLOBAL LC, INC DBA RICE CHICKEN - November 16, 2021

On February 4, 2022, the FDA issued a Warning Letter to Global LC Inc DBA Rice Chicken following Foreign Supplier Verification Program (FSVP) inspections conducted from November 3-16, 2021, and previously from October 24-November 5, 2019. The inspections revealed the firm's non-compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported food products, including batter mix from (b)(4) and mild taste marinade and roasted seasoning from (b)(4). This significant violation was noted in both the 2019 and 2021 inspections, with Form FDA 483a, FSVP Observations, issued.

While the FDA acknowledged the firm's November 18, 2021, response stating plans to formulate an FSVP, it was deemed inadequate due to the lack of a timeline and supporting documentation of corrective actions.

The FDA warned that failure to adequately address these violations could lead to further action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potential detention without