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

Source: https://www.keypedia.com/records/483/dowell-dental-products-inc/d414051b-7e5b-4f89-92f2-f38fc8682395

> FDA 483 for Dowell Dental Products Inc on June 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dowell Dental Products Inc
- Inspection Date: 2025-06-13
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/maurine-fadlalla/519e6e71-a50a-43b5-b41a-2249ec9afdd5)

Company: https://www.keypedia.com/companies/dowell-dental-products-inc/81f03c2d-83bc-4f5e-9e10-e5a74f5ea974

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6