FDA Inspection 1014229 — Keystone Dental Inc
The FDA completed an inspection of Keystone Dental Inc on June 8, 2017 in Burlington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |