Overview
- 15 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-01.
At a glance
Inspections
15
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jan 2024 – 1 Feb 2024 | Human Drugs | Clean | |
| 4 Jun 2019 – 11 Jun 2019 | Human Drugs | 483 | View 483 → |
| 14 Dec 2017 – 21 Dec 2017 | Human Drugs | Clean | |
| 12 Jun 2017 – 13 Jul 2017 | Human Drugs | 483 | On file |
| 18 Jul 2016 – 25 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 1 Dec 2015 – 7 Dec 2015 | Human Drugs | Clean | |
| 18 Nov 2013 – 25 Nov 2013 | Human Drugs | Clean | |
| 11 Sep 2012 | Not recorded | 483 | View 483 → |
| 14 Apr 2011 | Not recorded | Clean | |
| 17 Nov 2010 | Not recorded | 483 | On file |
| 27 Apr 2009 | Not recorded | 483 | View 483 → |
| 29 Nov 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Emmanuel J Ramos, Lata C Mathew
11 Jun 2019
21 CFR 211.68(b)
Computer control of master formula records
Cited by Emmanuel J Ramos, Lata C Mathew
11 Sep 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Justine Tomasso, Shahla Parvizi
Investigators
FDA investigators tied to this site in the record.
Melissa T Roy2 insp.
Douglas C Kovacs2 insp.
Karen E Dorazio2 insp.
Janet A Rajan1 insp.
Stephenie M Ortiz1 insp.
Emmanuel J Ramos1 insp.
Lata C Mathew1 insp.
Nancy F Scheraga1 insp.
Guerlain Ulysse1 insp.
Yvins Dezan1 insp.
Jose M Cayuela1 insp.
Zakaria I Ganiyu1 insp.
Liatte Krueger1 insp.
Stephen J Mottola1 insp.
Justine Tomasso1 insp.
Shahla Parvizi1 insp.
Charles Chacko1 insp.
Michael R Klapal1 insp.
Gianine E Tompkins1 insp.
Nicholas A Violand1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LTS Lohmann Therapy Systems Corp.'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