FDA Inspection 1325156 — Vynacron Dental Resins, Inc.
The FDA completed an inspection of Vynacron Dental Resins, Inc. on Jun 25, 2026 in Jackson, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jackson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23103 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs records not maintained |
| 23109 | ISO 13485:2016 Clause 7.3.4 | Records of design and development outputs not maintained |
| 23194 | ISO 13485:2016 Clause 7.6(a) | Measuring equipment not adequately calibrated or verified |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 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 |