Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
22 Apr 2026
21 CFR 312.57(a)
Records of receipt, shipment, disposition
Cited by Emily C Caldwell, Nicol Vargas
22 Apr 2026
21 CFR 50.25(a)(1)
Statement of research, purpose, duration of participation
Cited by Emily C Caldwell, Nicol Vargas
Inspected site
ENEdwin N. Lee, M.D.Orlando, United States
Inspection team
NVNicol Vargas
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.57(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.66 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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