Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-29.
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 |
|---|---|---|---|
| 22 Jul 2024 – 29 Jul 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Aug 2021 – 5 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Aug 2019 – 5 Sep 2019 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jul 2024
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Matthew M Vernon
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 1010.2(c) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 1040.11(a)(1) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 1040.11(a)(3) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1010.3(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1040.11(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | 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 820.30(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CureWave Lasers, 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