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FDA issues warnings to two importers for compliance failures

FDA has issued warning letters to two food firms for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The FSVP rule requires importers to verify that foods imported into the United States are produced in a manner that meets applicable U.S. food safety standards.

Failure to comply with FSVP requirements could allow unsafe food into the U.S. market. The agency may refuse admission of implicated products, place them on detention without physical examination (DWPE) under Import Alert #99-41, or pursue other actions. Importing without a compliant FSVP is a prohibited act.

The Great Smart African Food LLC

Cleveland, OH

In a Jan. 15, 2026, warning letter, FDA outlined violations found during an FSVP inspection from Oct. 23 through Dec. 16, 2025. The company failed to develop, maintain, and follow an FSVP for multiple imported foods, including:

Maize Flour from a supplier in (redacted by FDA)

Peanut Butter Biscuits from a supplier in (redacted by FDA)

Dried Milk from a supplier in (redacted by FDA)

During the inspection, the company provided invoices, bills of lading, and phytosanitary certificates, but did not explain how these documents addressed FSVP requirements. The FDA issued a Form FDA 483a, but the agency has received no response to date.

The full warning letter can be viewed here.

Fidelity Melon, Inc.

Newport Beach, CA

In a Jan. 29, 2026, warning letter, FDA detailed violations following an FSVP inspection conducted Dec. 17, 2025, through Jan. 2, 2026. The company failed to develop an FSVP for any imported foods, including:

Cantaloupe from a supplier in (redacted by FDA)

Seedless Watermelon from suppliers in (redacted by FDA)

The company provided some supplier documentation but did not review or apply it to an FSVP program. FDA issued a Form FDA 483a, and the company’s response lacked supporting documentation of corrective actions.

The full warning letter can be viewed here.

Source: Food Safety News (FSN)

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