FDA EIR - Friesland Campina Ingredients North America - June 13, 2019

The FDA conducted an inspection of Friesland Campina Ingredients North America's facility in Delhi, NY, on June 13, 2019. This inspection, carried out under the HAFE1 FY19 High Risk workplan and guided by the Compliance Program Guidance Manual 7303.803 (Domestic Food Safety) and DFPG #19-03 (Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls in Human Foods Inspections), focused on the company's production of Hyvital Whey Easy to Digest 100, an ingredient for infant formula. The firm is required to develop and maintain a written food safety plan. The inspection encompassed a review of the firm's food safety plan, risk assessments, procedures, environmental monitoring, complaint handling, and recall processes. A thorough walk-through was also conducted to observe the manufacturing process for ETD 100. Critically, the inspection revealed no significant deficiencies or issues. The company's operations and documentation, including its Critical Control Point for pathogen elimination and complaint management, were found to be satisfactory. As a result, no FDA 483 (Inspectional Observations) was issued, and no samples were collected. The report concluded without identifying any specific violations or requiring any mandatory actions from the company, indicating a compliant status at the time of the inspection.