Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-02-26.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2015 – 26 Feb 2015 | Human Drugs | Clean | |
| 14 Feb 2013 – 22 Feb 2013 | Human Drugs | Clean | |
| 11 Mar 2011 | Not recorded | Clean | |
| 11 Feb 2011 | Not recorded | 483 | View 483 → |
| 20 Aug 2010 | Not recorded | Clean | |
| 2 Feb 2009 | Not recorded | 483 | On file |
| 25 Aug 2008 | Not recorded | Clean | |
| 26 Mar 2008 | Not recorded | 483 | On file |
| 20 Apr 2007 | Not recorded | Clean | |
| 23 Mar 2006 | Not recorded | Clean | |
| 28 Jan 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Eric M Mueller, Verlinda A Narcisse, Adree N Anderson
11 Feb 2011
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Eric M Mueller, Verlinda A Narcisse, Adree N Anderson
11 Feb 2011
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Eric M Mueller, Verlinda A Narcisse, Adree N Anderson
11 Feb 2011
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Eric M Mueller, Verlinda A Narcisse, Adree N Anderson
11 Feb 2011
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Eric M Mueller, Verlinda A Narcisse, Adree N Anderson
Investigators
FDA investigators tied to this site in the record.
Michele Perry Williams3 insp.
Eric M Mueller3 insp.
Thuy T Nguyen2 insp.
Michele Perry-Williams1 insp.
Shafiq Ahadi1 insp.
Anthony Bucks1 insp.
Verlinda A Narcisse1 insp.
Adree N Anderson1 insp.
Matthew R Sleeter1 insp.
Sherry G Bous1 insp.
Matthew J Morrison1 insp.
Eric C Nielsen1 insp.
Kara L Roden1 insp.
Gwyn G Dickinson1 insp.
Tara L Breckenridge1 insp.
Jennifer Cahill1 insp.
Farhana Khan1 insp.
Shanna R Haden1 insp.
Erika V Butler1 insp.
Kathleen B Swat1 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 | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ther-RX Corporation's 3 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