Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-29.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Aug 2024 – 29 Aug 2024 | Biologics | Clean | |
| 28 Nov 2017 – 29 Nov 2017 | Biologics | Clean | |
| 19 Oct 2015 – 22 Oct 2015 | Biologics | 483 | View 483 → |
| 9 May 2013 – 10 May 2013 | Biologics | 483 | View 483 → |
| 15 Jun 2011 | Not recorded | Clean | |
| 1 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Oct 2015
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Lorie S Hannappel
Investigators
FDA investigators tied to this site in the record.
Janice M Hickok2 insp.
Ismael Olvera-Iv1 insp.
Richard T Riggie1 insp.
Lorie S Hannappel1 insp.
Young M Yoon1 insp.
Ernest Serna1 insp.
Anthony Adeuya1 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 606.65(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Saint Francis Hospital, Inc.'s 3 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