FDA EIR - United Exchange Corporation - February 14, 2018

An FDA inspection of United Exchange Corporation, located in Cypress, CA, was conducted on February 14, 2018. The inspection focused on the company's compliance with the Foreign Supplier Verification Program (FSVP) regulations, specifically under 21 CFR 1.502(a), as part of a surveillance initiative following Division of Field Programs and Guidance # 18-04. The primary objective was to assess the importer's adherence to FSVP requirements for imported food products.

The inspection identified a significant issue: United Exchange Corporation had not developed or implemented the necessary FSVP procedures for their imported "Tapatio Ramen Big Bowl with Artificial Beef Flavor." This included a lack of proper hazard analysis evaluation, documented verification activities, and written procedures for approving foreign food suppliers. A presented HACCP certification for a foreign supplier was deemed insufficient as it did not demonstrate equivalence to U.S. food safety standards. The company's existing supplier checklist was also found to be inadequate, as it was designed for medical products, not food.

As a result, an FDA-483a form was issued, detailing these observations. Management was informed of the requirement to develop and establish comprehensive FSVP procedures for food products, communicate with foreign suppliers to obtain compliance documentation, and create a food-specific supplier evaluation checklist. A formal response addressing these findings was required within 15 business days.