FDA Inspection 1318234 — Toothsmiths Incorporated
The FDA completed an inspection of Toothsmiths Incorporated on May 21, 2026 in Lititz, PA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lititz, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23064 | ISO 13485:2016 Clause 5.6.2 | Input to management review is incomplete |
| 23171 | ISO 13485:2016 Clause 7.5.6 | Procedures for production/service provision software validation not documented |