FDA WARNING_LETTER - SHOULY IMPORT CORP - April 30, 2026

Shouly Import Corp., located in Clifton, New Jersey, received a formal Warning Letter from the FDA following a Foreign Supplier Verification Program (FSVP) inspection conducted on April 30, 2026. This evaluation was performed under the regulatory framework of the Federal Food, Drug, and Cosmetic Act to ensure that imported foods meet U.S. safety standards. The primary violation identified was the company’s failure to develop, maintain, and follow an FSVP for any of the food products it imports. Specific examples of items lacking required safety oversight include Roasted White Sesame, Feta cheese, and Classic Baklava.

While the company responded to initial inspection findings by stating they had hired a consultant and planned to implement full safety programs within six months, the FDA found this response inadequate. The agency noted that Shouly Import Corp. failed to provide any supporting documentation or evidence that corrective actions had actually been taken. To resolve these issues, the firm must submit a written response within 15 working days detailing their corrective measures and providing tangible proof of compliance, such as copies of their newly established verification records. Failure to adequately address these violations may result in the FDA refusing entry of the company’s products into the United States or placing them on a detention list at the border.