DING TEA BALBOA – FDA Warning Letter, Sep 17, 2021

On December 9, 2021, the FDA issued a Warning Letter to Ding Tea Balboa following Foreign Supplier Verification Program (FSVP) inspections on August 23 and September 16-17, 2021, and a previous inspection on March 22, 2019. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandates importers to conduct risk-based activities to ensure imported food meets U.S. safety standards.

The FDA found Ding Tea Balboa non-compliant, specifically citing a failure to develop, maintain, and follow an FSVP for imported foods, including Thai Tea Powder, (b)(4), and Hazelnut Syrup. This violation was also noted in the 2019 inspection. The firm's September 18, 2021, response to the FDA 483a, stating a one-year timeline for FSVP readiness, was deemed inadequate due to a lack of supporting documentation. Despite the firm's claim of no longer importing these products, shipping history indicated continued importation.

The FDA warned of potential actions, including refusal of admission under Section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under Section