FDA WARNING_LETTER - Global Trade Bridge Corporation - December 23, 2020

On December 15-23, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Mr. Pina's submitted records, following a previous inspection on September 11, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The inspection revealed significant violations for imported sugar, virgin coconut oil, garlic paste, soda crackers, and cassava bread. A Form FDA 483a FSVP Observations was issued on December 23, 2020, to which no response has been received.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for sugar and virgin coconut oil (21 CFR 1.502(a)). 2. Failure to document review and assessment of foreign supplier hazard analyses for cassava bread and garlic paste, including confirmation that the garlic paste analysis was conducted by a qualified individual (21 CFR 1.504(d)). 3. Failure to evaluate foreign supplier performance and food risk, and to document approval of foreign suppliers for garlic paste and soda crackers (21 CFR 1.505(a) and (b)). 4. Failure to determine and