Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-04.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Aug 2018 – 4 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2013 | Medical Devices & Rad Health | 483 | On file |
| 23 Mar 2012 | Not recorded | 483 | On file |
| 26 Apr 2011 | Not recorded | Clean | |
| 15 Oct 2008 | Not recorded | Clean | |
| 15 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Sep 2018
21 CFR 1010.3(a)(2)
ID label lacks place, month & year of manufacture
Cited by Dennis R Hock
Investigators
FDA investigators tied to this site in the record.
Leo J Lagrotte2 insp.
Dennis R Hock1 insp.
Karen M Rodriguez1 insp.
Craig A Garmendia1 insp.
Dawn M Mccabe1 insp.
James E Frye1 insp.
Emir Galevi1 insp.
Tina A Desorcy1 insp.
Don A Leeseberg1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.30(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.3(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.4(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(h)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lightwave International, LLC's 3 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