Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
VDVynacron Dental Resins, Inc.Jackson, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere