BlendHouse Portland LLC – FDA EIR

An FDA inspection of Cascadia Nutrition, an infant powdered formula manufacturer for export only, was conducted from June 4-5, 2018. This initial inspection, performed under Compliance Program 7303.803 (Domestic Food Safety Program / cGMP), aimed to assess the firm's adherence to regulatory standards for its products, which are subject to the Food, Drug, and Cosmetic Act. While no Form FDA-483 (Inspectional Observations) was issued, the inspectors discussed two key issues with management. First, Cascadia Nutrition lacked a statement or letter from its export countries verifying compliance with Section 801(e) of the FD&C Act, which is crucial for export-only products. Second, the FDA required updated information regarding additional export countries, the current manufacturing facility address, contact details for responsible persons, and revised label information for their "American Choice Infant Formula." In response, Cascadia Nutrition's management committed to securing the required 801(e) compliance letters from export countries by June 18, 2018. They also pledged to provide the FDA's Infant Formula and Medical Food Staff with all updated contact and label information within the following week. This inspection highlighted the importance of robust documentation and accurate regulatory communication for firms engaged in international food trade.