Overview
- 5 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.
5 Mar 2026
21 CFR 820.35(c)
UDI was not recorded for each medical device or batch
Cited by Gamal A Norton
5 Mar 2026
ISO 13485:2016 Clause 6.2(e)
Records of personnel competence not maintained
Cited by Gamal A Norton
5 Mar 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Gamal A Norton
5 Mar 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities are inadequate
Cited by Gamal A Norton
5 Mar 2026
ISO 13485:2016 Clause 7.5.4
Records of servicing activities not maintained
Cited by Gamal A Norton
Inspected site
RIREACT Innovations, LLCCharlotte, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.35(c) | 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 7.3.10 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.4 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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