FDA Inspection 1272591 — Dowell Dental Products Inc
The FDA completed an inspection of Dowell Dental Products Inc on June 13, 2025 in Rancho Cucamonga, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |