Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-25.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2026 – 25 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2024 – 21 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 11 May 2018 – 16 May 2018 | Medical Devices & Rad Health | 483 | On file |
| 24 Oct 2014 – 29 Oct 2014 | Medical Devices & Rad Health | 483 | On file |
| 1 Dec 2011 | Not recorded | 483 | View 483 → |
| 4 Sep 2008 | Not recorded | Clean | |
| 19 Feb 2004 | Not recorded | Clean | |
| 29 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jun 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Shirley S Wen
25 Jun 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Shirley S Wen
25 Jun 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs records not maintained
Cited by Shirley S Wen
25 Jun 2026
ISO 13485:2016 Clause 7.3.4
Records of design and development outputs not maintained
Cited by Shirley S Wen
25 Jun 2026
ISO 13485:2016 Clause 7.6(a)
Measuring equipment not adequately calibrated or verified
Cited by Shirley S Wen
Investigators
FDA investigators tied to this site in the record.
Shirley S Wen2 insp.
Matthew W Kyle1 insp.
Jaro P Perera1 insp.
Kwong P Lee1 insp.
Gobiga Vanniyasingam1 insp.
Doreen P Gubbay1 insp.
Kristen E Rescigno1 insp.
Dawn L Wydner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vynacron Dental Resins, Inc.'s 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat