Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-03-07.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2025 – 7 Mar 2025 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Mar 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Alexander M Kay, Creighton T Tuzon, Nisha C Patel
7 Mar 2025
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Alexander M Kay, Creighton T Tuzon, Nisha C Patel
7 Mar 2025
21 CFR 820.90(a)
Nonconforming product control
Cited by Alexander M Kay, Creighton T Tuzon, Nisha C Patel
7 Mar 2025
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Alexander M Kay, Creighton T Tuzon, Nisha C Patel
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aeon Biotherapeutics Corp.'s 1 Form 483
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