Overview
- 10 public-safe observations are available for this inspection.
- 5 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.
24 Mar 2026
ISO 13485:2016 Clause 4.1.6
Records of QMS software validation not maintained
Cited by Brandon P Thompson
24 Mar 2026
ISO 13485:2016 Clause 4.1.6
Records of QMS software validation not maintained
Cited by Brandon P Thompson
24 Mar 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Brandon P Thompson
24 Mar 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Brandon P Thompson
24 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Brandon P Thompson
Inspected site
SDSurgical Direct, Inc.Orange City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.6 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 10 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