Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-12.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2026 – 12 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Dec 2021 – 10 Dec 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jan 2018 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Kenya Destin
12 May 2026
ISO 13485:2016 Clause 8.2.2
Lack of documented justification for not investigating complaint(s)
Cited by Kenya Destin
12 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Kenya Destin
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | 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 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vivalnk, Inc.'s 2 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