FDA EIR - Nutrition & Biosciences USA 1 LLC - February 06, 2025

An FDA contract Full Scope Preventive Controls inspection was conducted at Nutrition & Biosciences USA 1, LLC- Ethocel on February 6, 2025, in Midland, Michigan. This facility manufactures Ethocel, a food-grade ethylcellulose additive used in various food applications. The inspection evaluated the firm's adherence to the regulatory framework outlined in 21 CFR Part 117, encompassing Subpart C for Hazard Analysis and Risk-Based Preventive Controls, and Subpart G for the Supply Chain program. The comprehensive assessment covered all critical areas, including the firm

’s hazard analysis, food safety plan implementation, sanitation practices, allergen management (none present), product testing, lot coding, employee training, and pest control measures. Notably, the inspection concluded with no violations or deficiencies observed. The firm demonstrated robust preventive controls, particularly for metal inclusion, a well-managed supply chain program, and an effective environmental monitoring system. Complaint handling and recall procedures, including a successful recent mock recall, were also found to be compliant. Consequently, no corrective or required actions were mandated following this inspection, affirming the firm's satisfactory compliance with applicable regulations.