Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-15.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Aug 2024 – 15 Aug 2024 | Biologics | Clean | |
| 4 Feb 2019 | Biologics | 483 | View 483 → |
| 13 Mar 2017 | Biologics | Clean | |
| 24 Nov 2015 | Biologics | Clean | |
| 15 Jan 2014 – 23 Jan 2014 | Biologics | Clean | |
| 17 Apr 2012 | Not recorded | 483 | View 483 → |
| 3 Sep 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Feb 2019
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Kathleen B Swat
17 Apr 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Terrance L Thomas
Investigators
FDA investigators tied to this site in the record.
Eric Zhu1 insp.
Kathleen B Swat1 insp.
Doretha M Tonkins1 insp.
Laurissa S Flowers1 insp.
Doretha M Wilson1 insp.
Ka L Wong1 insp.
Yvonne C Wilkes1 insp.
Terrance L Thomas1 insp.
Lawrence H Howell1 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 |
Full site report
Get the verbatim findings behind Mission Hospital Regional Medical Center's 2 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