FDA WARNING_LETTER - Transu Investment Group, LLC - March 05, 2021

On July 16, 2021, the FDA issued a Warning Letter to TRANSU INVESTMENT GROUP, LLC, following Foreign Supplier Verification Programs (FSVP) inspections conducted from February 26 to March 5, 2021, and previously on March 4, 2019. The inspections, at 1386 Belt Line Rd, Richardson, Texas, aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The FDA found significant violations regarding imported pineapple syrup, red beans, and honey syrup. The company failed to: 1. Document review and assessment of foreign suppliers' hazard analyses, including verification that analyses were conducted by qualified individuals (21 CFR 1.504(d)). 2. Document review and assessment of foreign supplier evaluations conducted by another entity, including verification that evaluations were conducted by qualified individuals (21 CFR 1.505(d)). 3. Establish and follow written procedures for approving foreign suppliers based on performance and risk (21 CFR 1.506(a)(1)). 4. Establish and follow adequate written procedures for conducting foreign supplier verification activities (21 CFR 1.506(b)). 5. Determine and document required verification activities and frequencies for imported foods (21 CFR 1.506(d)). 6. Verify and