Overview
- 15 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-27.
At a glance
Inspections
15
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2024 – 27 Mar 2024 | Biologics | Clean | |
| 25 Apr 2022 – 29 Apr 2022 | Biologics | Clean | |
| 1 Jul 2021 – 6 Aug 2021 | Biologics | 483 | On file |
| 1 Jul 2021 – 19 Jul 2021 | Biologics | Clean | |
| 5 Feb 2018 – 9 Feb 2018 | Biologics | 483 | View 483 → |
| 2 Dec 2015 – 4 Dec 2015 | Biologics | Clean | |
| 11 Mar 2014 – 12 Mar 2014 | Biologics | Clean | |
| 30 Aug 2012 | Not recorded | Clean | |
| 13 Sep 2010 | Not recorded | Clean | |
| 8 Nov 2007 | Not recorded | Clean | |
| 3 Dec 2004 | Not recorded | Clean | |
| 24 Oct 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2018
21 CFR 630.10(g)(2)(ii)
Donor's Acknowledgment - Exculpatory language
Cited by Lura D Baquero
Investigators
FDA investigators tied to this site in the record.
Doretha M Wilson3 insp.
Linda K Matheny2 insp.
Ivan E Reyes1 insp.
Nerming V Briones1 insp.
Lura D Baquero1 insp.
Mizanne E Lewis1 insp.
Leroy Terrelonge1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 630.10(g)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lee Memorial Health System'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