Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-23.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Aug 2019 – 23 Aug 2019 | Biologics | 483 | View 483 → |
| 23 Feb 2016 – 4 Mar 2016 | Biologics | 483 | View 483 → |
| 25 Feb 2014 – 4 Mar 2014 | Biologics | 483 | View 483 → |
| 29 Feb 2012 | Not recorded | 483 | View 483 → |
| 29 Jul 2010 | Not recorded | Clean | |
| 30 Sep 2008 | Not recorded | Clean | |
| 13 Dec 2002 | Not recorded | Clean | |
| 2 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2019
21 CFR 606.171
Biological product deviation report
Cited by Amanda B Athey, Erika M Wilkerson, Carl E Lovrich, Amanda B Vega
29 Feb 2012
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Travis R Hunt, Marjorie L Davis
Investigators
FDA investigators tied to this site in the record.
Travis R Hunt3 insp.
Erica L Nicoll2 insp.
Amanda B Athey1 insp.
Erika M Wilkerson1 insp.
Carl E Lovrich1 insp.
Amanda B Vega1 insp.
Marjorie L Davis1 insp.
Mary R Kirker1 insp.
Michael J Diskin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ITXM Clinical Services' 4 Form 483s
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