Overview
- 14 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-30.
At a glance
Inspections
14
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 30 Sep 2025 | Human Drugs | 483 | On file |
| 18 Sep 2023 – 20 Sep 2023 | Medical Devices & Rad Health | Clean | |
| 28 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2019 – 31 Jan 2019 | Human Drugs | 483 | View 483 → |
| 20 Mar 2017 – 29 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 Jan 2015 – 14 Jan 2015 | Human Drugs | Clean | |
| 19 Mar 2014 – 25 Mar 2014 | Human Drugs | 483 | View 483 → |
| 3 May 2012 | Not recorded | Clean | |
| 7 May 2010 | Not recorded | Clean | |
| 5 Apr 2010 | Not recorded | Clean | |
| 2 Jul 2008 | Not recorded | Clean | |
| 21 Jul 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2019
21 CFR 211.182
Written records kept in individual logs
Cited by Courtney R Ingalsbe, James K Ireland
31 Jan 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Courtney R Ingalsbe, James K Ireland
29 Mar 2017
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Anthony J Ladner, James K Ireland
29 Mar 2017
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Anthony J Ladner, James K Ireland
29 Mar 2017
21 CFR 211.167(c)
Controlled release test methods written, followed
Cited by Anthony J Ladner, James K Ireland
Investigators
FDA investigators tied to this site in the record.
Marie A Fadden3 insp.
James K Ireland2 insp.
Ivan E Reyes2 insp.
Robert J Ham1 insp.
Soyinka S Eneng1 insp.
Ralph W Jerndal1 insp.
Benjamin W Anderson1 insp.
Courtney R Ingalsbe1 insp.
Anthony J Ladner1 insp.
Denise L Burosh1 insp.
April L Young1 insp.
Susan M Matthias1 insp.
Kellie L Westerbuhr1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LTS Therapy Systems, LLC's 4 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