Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Jun 2025
21 CFR 1271.180(a)
Procedures to meet core CTGP
Cited by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones
6 Jun 2025
21 CFR 1271.230(a)
Process validation procedures
Cited by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones
6 Jun 2025
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones
6 Jun 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones
6 Jun 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones
Inspected site
LTLux Therapeutics LLCBrookhaven, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 observations
The source PDF, 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