Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-05.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2026 – 5 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Feb 2023 – 17 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Gamal A Norton2 insp.
Babatunde D Babalola1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.170(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 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 site report
Get the verbatim findings behind REACT Innovations, LLC's 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat