Overview
- 12 public-safe observations are available for this inspection.
- 11 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.
8 Apr 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Javonica F Penn
8 Apr 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Javonica F Penn
8 Apr 2026
ISO 13485:2016 Clause 4.1.5
External party controls do not include written quality agreements
Cited by Javonica F Penn
8 Apr 2026
ISO 13485:2016 Clause 4.2.3
Medical device file not established and maintained
Cited by Javonica F Penn
8 Apr 2026
ISO 13485:2016 Clause 5.6.1
QMS not reviewed by top management at documented planned intervals
Cited by Javonica F Penn
Inspected site
SLSteribite, LLCWooster, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 830.300(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 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.3 | 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 6.2(e) | 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 7.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 12 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