FDA Inspection 1094404 — Servi-Dent Inc.
The FDA completed an inspection of Servi-Dent Inc. on June 27, 2019 in Coral Gables, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Coral Gables, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |