Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
11 Jun 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Laureen M Geniusz
11 Jun 2026
ISO 13485:2016 Clause 4.2.4
Document Control Procedure Inadequate
Cited by Laureen M Geniusz
11 Jun 2026
ISO 13485:2016 Clause 7.3.5
Records of design and development reviews not maintained
Cited by Laureen M Geniusz
Inspected site
STSurgical Theater IncBeachwood, 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 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.5 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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