Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-10-04.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Sep 2018 – 4 Oct 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Oct 2013 – 1 Nov 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 May 2008 | Not recorded | Clean | |
| 24 May 2007 | Not recorded | Clean | |
| 10 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Nov 2013
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Marc S Neubauer
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 | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LSI Solutions, Inc.'s 2 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