FDA WARNING_LETTER - Express Trading International Inc. - February 19, 2020

The FDA conducted Foreign Supplier Verification Program (FSVP) inspections on July 17, 2018, and February 19, 2020, at 401 B Street, Suite 2310, San Diego, CA, to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 subpart L. The firm was found not in compliance, specifically failing to develop, maintain, and follow an FSVP for imported Canned Coconut Milk and Aloe Vera Drink Pomegranate from foreign supplier (b)(4). This constitutes a significant violation of 21 CFR 1.502(a). Despite receiving Form 483a observations at both inspections and repeatedly promising to establish an FSVP by specific dates, the firm has not provided sufficient documentation or evidence of compliance. The FDA requires a written response within fifteen working days detailing corrective actions, including a copy of the revised FSVP and records demonstrating its implementation. Failure to promptly correct these violations may result in refusal of admission for the implicated products under Section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) via Import Alert #99-41. Furthermore, importation without a compliant FSVP is prohibited under Section 301(zz) of the FD&C Act.