FDA 483 - Van Elderen, Inc. - March 06, 2025

Van Elderen, Inc. in Martin, MI, was inspected from March 3-6, 2025, and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's preventive controls, specifically regarding the identification and mitigation of pathogen reintroduction hazards in various products. Additionally, the firm's product testing procedures were found to be incomplete, lacking defined corrective actions for pathogen detection.