FDA 483 - Purunchon, Inc - September 16, 2020

CHUNCHON INC. in Fullerton, CA, underwent an FDA inspection focused on its Foreign Supplier Verification Program (FSVP). The inspection revealed two significant issues: the firm failed to establish written procedures for foreign supplier verification activities and lacked documented approval of its foreign suppliers, specifically for imported Seaweed Spicy snack from South Korea. These observations indicate a lack of proper controls and documentation for imported food safety.