Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
LMLee Memorial Health System IRCCape Coral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 3 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere