Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
29 Oct 2021
21 CFR 211.110(a)
Written in-process control procedures
Cited by Jennifer Lalama, Kayla V Sprague
29 Oct 2021
21 CFR 211.186(b)(7)
Theoretical Yield and Percentages
Cited by Jennifer Lalama, Kayla V Sprague
29 Oct 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer Lalama, Kayla V Sprague
29 Oct 2021
FDCA 503B(b)(2)(A)
Outsourcing facility, compounded drug report follow up
Cited by Jennifer Lalama, Kayla V Sprague
Inspected site
LILEESAR, INCFort Myers, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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