Carive Imports Inc – FDA Warning Letter, Apr 22, 2026

On October 13, 2026, the FDA issued a warning letter to Carive Imports Inc. following a series of inspections, the most recent of which occurred between March 30, 2026, and April 22, 2026. The inspection aimed to determine the company"s compliance with the Foreign Supplier Verification Program (FSVP) requirements under Section 805 of the Federal Food, Drug, and Cosmetic Act. This regulatory framework requires importers to perform risk-based activities to ensure that imported food meets U.S. safety standards. The primary violation identified was the firm"s failure to provide any FSVP records to the agency. Despite multiple written and verbal requests from investigators, the company failed to submit documentation for several imported products, including garlic paste, cookies, noodles, and pigeon peas. Furthermore, the company did not respond to the initial observation report issued at the end of the inspection. The FDA has required Carive Imports Inc. to respond within 15 working days with a detailed plan for corrective actions and evidence that they have implemented the necessary safety verification programs. Failure to address these deficiencies may lead to serious consequences, such as the refusal of imported food at the border or placing the products on a detention list. This letter emphasizes the legal obligation of importers to maintain transparent records that verify the safety of food products sourced from foreign suppliers.