Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-16.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2024 – 16 Dec 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Mar 2023 – 29 Mar 2023 | Medical Devices & Rad Health | WL | View 483 → |
| 21 Mar 2022 – 31 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Dec 2018 – 21 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jan 2018 – 29 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2024
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Christine I Shaw
16 Dec 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Christine I Shaw
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 | 6x |
| 21 CFR 820.20(b)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind WAVi Co.'s 5 Form 483s
Source PDFs, verbatim observations, 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