FDA 483 - GENOMMA LAB USA INC - June 24, 2025

GENOMMA LAB USA INC was inspected by the FDA from June 23-24, 2025, regarding its Foreign Supplier Verification Program (FSVP). The inspection, conducted under the Federal Food, Drug and Cosmetic Act, identified a significant observation: the company failed to develop an FSVP for all imported foods. Specifically, the FDA noted that GENOMMA LAB USA INC confirmed the absence of an FSVP for several categories of imported products. These included noncarbonated (non-medicinal) flavors, bottled water with fruit flavors, and nutritive food sweeteners, all sourced from various foreign suppliers. This lack of a documented program covers imports from at least January 15, 2025, to April 16, 2025, and potentially other foods imported between June 1, 2024, and May 31, 2025, as detailed in an attached list. This observation indicates a failure to establish a system for verifying that foreign suppliers are producing food in compliance with U.S. safety standards. To address this, GENOMMA LAB USA INC must develop and implement a comprehensive Foreign Supplier Verification Program for all imported food products to ensure regulatory compliance and product safety.