Dowell Dental Products IncJune 13, 2025

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

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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.

Company: Dowell Dental Products Inc
Inspection Date: June 13, 2025
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Maurine Fadlalla (FDA_PERSONNEL)

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ID · d414051b-7e5b-4f89-92f2-f38fc8682395