Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-08-10.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Aug 2016 – 10 Aug 2016 | Medical Devices & Rad Health | Clean | |
| 20 Aug 2010 | Not recorded | 483 | View 483 → |
| 13 Jul 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Aug 2010
21 CFR 56.108(b)(1)
Prompt reporting of unanticipated problems
Cited by Joshua J Silvestri, Leroy Terrelonge
20 Aug 2010
21 CFR 56.108(b)(3)
Reporting of suspension/termination
Cited by Joshua J Silvestri, Leroy Terrelonge
20 Aug 2010
21 CFR 56.115(a)(4)
Copies of IRB/CI correspondence
Cited by Joshua J Silvestri, Leroy Terrelonge
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lee Memorial Health System IRC's 1 Form 483
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