DingMoo LLC – FDA Warning Letter, Feb 14, 2025

DingMoo LLC, operating as Dingman’s Dairy, located in Paterson, NJ, was subject to an FDA inspection from February 7 to February 14, 2025, under the Foreign Supplier Verification Program (FSVP). The inspection aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act and related FSVP regulations. The FDA identified significant violations, including the failure to establish and follow written procedures for approving foreign suppliers based on risk evaluations and supplier performance, as mandated by 21 CFR part 1, subpart L.

Key issues included the absence of documented hazard analyses for imported foods, such as frozen desserts and Pistachio Tartufo, and the lack of documented evaluations of foreign suppliers" performance and associated risks. These shortcomings were highlighted in light of a multistate Salmonella Enteritidis outbreak linked to a foreign supplier, resulting in a Class 1 recall and the placement of certain products on Import Alerts #99-19 and #99-43.

The FDA requires DingMoo LLC to implement corrective actions, including establishing written procedures for supplier approval and verification, conducting thorough hazard analyses, and documenting evaluations of supplier performance. The company must ensure compliance with FSVP regulations to verify that imported foods meet U.S. safety standards. The FDA acknowledged receipt of a response from DingMoo LLC dated March 7, 2025, but emphasized the need for further corrective measures to address the identified violations.