Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Apr 2026
21 CFR 820.35(c)
UDI was not recorded for each medical device or batch
Cited by Marvin A Marenco, Pascal G Felix
1 Apr 2026
ISO 13485:2016 Clause 4.1.3
QMS processes not adequate
Cited by Marvin A Marenco, Pascal G Felix
1 Apr 2026
ISO 13485:2016 Clause 5.1
Lack of evidence for top management's commitment to QMS
Cited by Marvin A Marenco, Pascal G Felix
1 Apr 2026
ISO 13485:2016 Clause 7.1
Required elements not determined in planning product realization
Cited by Marvin A Marenco, Pascal G Felix
Inspected site
SDSun Dental Laboratories, LLCSaint Petersburg, United States
Inspection team
PGPascal G Felix
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | 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