The U.S. Food and Drug Administration (FDA) has issued a warning letter to Country Favor Inc., a food importer based in Maspeth, NY, citing serious violations of the Foreign Supplier Verification Program (FSVP)—a critical regulatory requirement designed to protect the safety of imported food.

The letter, dated March 14, 2025, follows a follow-up inspection conducted on February 13, which revisited concerns first raised during an earlier inspection between June 1 and July 5, 2023. The FDA’s enforcement process typically allows companies ample time—often months or even years—to resolve compliance issues before a formal warning is issued.

What is FSVP and Why It Matters

Under the FSVP rule, importers must verify that the food they bring into the United States meets the same safety standards as food produced domestically. This includes assessing and documenting that their foreign suppliers are producing food in compliance with U.S. food safety regulations.

Failure to meet these standards can allow unsafe food to enter the U.S. market, posing risks to public health.

Key Violations Found

During the February inspection, FDA investigators found that Country Favor Inc.:

• Had no FSVP procedures in place for foods imported from multiple foreign suppliers.
• Had not taken any corrective actions in response to a previous inspection’s findings.
• Did not respond to either of the FDA’s formal notices (Form FDA 483a) issued in July 2023 and again in February 2025, both of which documented the same violations.

Potential Consequences

The FDA stressed that continuing to import food without an appropriate FSVP is a prohibited act under federal law. If the company does not take corrective action, the FDA may pursue further enforcement, which could include:

• Refusing entry of products into the U.S.
• Detaining shipments without physical examination under Import Alert #99-41, effectively barring the products from entering the country.

The FDA clarified that the March 14 warning letter does not list all possible violations, but serves as a formal notice that Country Favor Inc. must act immediately to bring its operations into compliance with the Federal Food, Drug, and Cosmetic Act and FSVP regulations.

Next Steps for the Company

Country Favor Inc. has 15 business days from the date of the letter to respond with a detailed plan of corrective actions. Failing to respond or to comply with FSVP requirements could escalate the situation further.

Source: FSN

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