Overview
- 2 public-safe observations are available for this inspection.
- 2 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.
14 May 2026
ISO 13485:2016 Clause 7.3.9
Records of design and development changes and their reviews not maintained
Cited by Gamal A Norton
14 May 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Gamal A Norton
Inspected site
BSBionen S.r.l.Florence, Italy
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 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