FDA Inspection 1310438 — Sun Dental Laboratories, LLC
The FDA completed an inspection of Sun Dental Laboratories, LLC on Apr 1, 2026 in Saint Petersburg, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23020 | ISO 13485:2016 Clause 4.1.3 | QMS processes not adequate |
| 23049 | ISO 13485:2016 Clause 5.1 | Lack of evidence for top management's commitment to QMS |
| 23089 | ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |
| 23267 | 21 CFR 820.35(c) | UDI was not recorded for each medical device or batch |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |