FDA WARNING_LETTER - HH FRESH TRADING CORP - March 04, 2024

The U.S. Food and Drug Administration (FDA) issued a warning letter to HH Fresh Trading Corp following an inspection of its Los Angeles facility conducted between February 21 and March 4, 2024. The inspection was triggered after FDA laboratory testing identified Listeria monocytogenes in a shipment of fresh Enoki mushrooms imported by the company. The regulatory agency determined that the firm failed to meet the requirements of the Foreign Supplier Verification Program (FSVP) as mandated by the Federal Food, Drug, and Cosmetic Act.

The primary violation was the company"s failure to develop and maintain an FSVP for its imported products, including Enoki mushrooms, seafood mushrooms, and bamboo shoots. These programs are necessary to verify that foreign suppliers follow safety standards equivalent to U.S. regulations, such as the Produce Safety Rule. Although HH Fresh Trading Corp voluntarily destroyed the contaminated mushroom shipment and provided an initial response to the FDA’s findings, the agency noted that the response lacked supporting documentation to prove that corrective actions were actually implemented.

HH Fresh Trading Corp is required to respond in writing within 15 working days. This response must include specific evidence of compliance, such as copies of their FSVP plans and records of implementation. Failure to 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.