Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-29.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jun 2026 – 29 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Aug 2021 – 25 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Alicia U Jacobo
29 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective action records not maintained
Cited by Alicia U Jacobo
25 Aug 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joseph D Gong, Tyler R Courtney
25 Aug 2021
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Joseph D Gong, Tyler R Courtney
25 Aug 2021
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Joseph D Gong, Tyler R Courtney
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 | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | 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 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind VivaQuant, Inc.'s 2 Form 483s
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