Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-06.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2025 – 6 Jun 2025 | Biologics | WL | View 483 → |
| 8 May 2023 – 12 May 2023 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Mizanne E Lewis2 insp.
Jannet M Peroti1 insp.
Nerming V Briones1 insp.
Fabian N Chaparro-Rodriguez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 211.150 | 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lux Therapeutics LLC's 2 Form 483s
Source PDFs 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