FDA 483 - Dowell Dental Products Inc - June 13, 2025

Dowell Dental Products Inc, an HCT/Ps distributor in Rancho Cucamonga, CA, was inspected by the FDA. The inspection revealed significant issues with temperature monitoring and storage of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, the firm failed to record storage temperatures for HCT/Ps and stored HCT/Ps outside of appropriate temperature ranges, leading to the distribution of unmonitored products.