DairiConcepts, L.P. – FDA EIR, Aug 17, 2019

This report details a routine, comprehensive surveillance inspection of DairiConcepts, L.P., located in Allerton, IA, conducted by the U.S. Food and Drug Administration (FDA) from January 14-15, 2020. The inspection aimed to assess the firm's compliance with regulatory standards, utilizing guidance from FDA Compliance Program Guidance Manuals related to Infant Formula and Preventive Controls for Human Food Operations, in line with the Food, Drug, and Cosmetic Act and Food Safety Modernization Act principles. DairiConcepts operates as a contract manufacturer of powdered milk protein ingredients. During this visit, the firm was not producing infant formula premix. The inspection encompassed various aspects, including facility operations, administrative data, the food safety plan, preventive controls, sanitation programs, training, recall procedures, and pest control. A thorough walkthrough of the facility was performed, and a reconciliation exam was conducted. Notably, no objectionable conditions were observed during this inspection. Consequently, a Form FDA 483, "Inspectional Observations," was not issued to DairiConcepts, L.P., indicating no main violations or issues were found. The investigator concluded the inspection by reminding management of their ongoing responsibility to maintain compliance with all applicable FDA regulations.