FDA Inspection
Vynacron Dental Resins, Inc.Vynacron Dental Resins, Inc. – FDA Inspection, Jun 25, 2026
Record Details
This FDA Inspection record concerns Vynacron Dental Resins, Inc., with an inspection on June 25, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- Vynacron Dental Resins, Inc.
- Inspection Date
- June 25, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 01c0031f-d4a2-4d63-8750-2bf34b144400
Inspection Facts
- Inspection number
- 1325156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 7.3.3Design and development inputs records not maintained
- ISO 13485:2016 Clause 7.3.4Records of design and development outputs not maintained
- ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vynacron Dental Resins, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2025 | OAI | New Jersey District Office | Compliance: Medical Devices |
| August 26, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vynacron Dental Resins, Inc.
- FDA Inspection 1259194 - 2025-01-21
- FDA Inspection 1179084 - 2022-08-26
- FDA Inspection 1053522 - 2018-05-16
- FDA Inspection 901251 - 2014-10-29
- FDA Inspection 755049 - 2011-12-01
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