FDA WARNING_LETTER - World Candy Store Llc - September 11, 2020

On November 3, 2020, the FDA issued a Warning Letter to World Candy Store LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from September 3-11, 2020, at their Brownsville, Texas location. A previous inspection occurred on August 17, 2017. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The FDA found World Candy Store LLC non-compliant, specifically noting the absence of FSVPs for imported products like Ricolino Huevito Pinto and Ricolino Huevito. This violates 21 CFR 1.502(a), which requires developing, maintaining, and following an FSVP. Despite receiving Form FDA 483a observations in both 2017 and 2020, and a response dated October 2, 2020, indicating a hired individual to create an FSVP, no actual FSVP documents or records have been provided.

The FDA stated it could refuse admission of imported food products under Section 801(a)(3) of the FD&C Act and place them on detention without physical examination (DWPE) via Import Alert #99-41. Importing