Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-04-03.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Apr 2024 – 3 Apr 2024 | Biologics | Clean | |
| 11 Sep 2018 – 12 Sep 2018 | Biologics | Clean | |
| 2 Jun 2015 – 3 Jun 2015 | Biologics | Clean | |
| 15 Jul 2013 – 16 Jul 2013 | Biologics | Clean | |
| 3 Jun 2011 | Not recorded | Clean | |
| 16 Sep 2009 | Not recorded | Clean | |
| 14 May 2008 | Not recorded | 483 | On file |
| 19 Jul 2002 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Kathryn A Krentz2 insp.
Paul M Chefor1 insp.
Julian C Hanson1 insp.
Dianna D Wardlow-Dotter1 insp.
Gloria J Baca1 insp.
Alexander M Kay1 insp.
Full site report
Get the verbatim findings behind St. Charles Health System's 1 Form 483
The full inspection record, as Atlas holds it, 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