Davion Inc – FDA 483, Jul 17, 2024

Davion Inc. in North Brunswick, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing and quality control processes for over-the-counter drug products. Observations included failures in quality unit oversight of contract lab testing, inadequate storage conditions and temperature mapping for raw materials and finished products, and deficient annual drug product review procedures. Additionally, the firm lacked proper controls for raw material sampling, leading to potential contamination risks.