Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 2 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Mar 2023 – 23 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Feb 2016 – 4 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2026
ISO 13485:2016 Clause 6.3
Requirements for infrastructure not documented
Cited by Jesse A Vazquez
2 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Jesse A Vazquez
2 Apr 2026
ISO 13485:2016 Clause 8.2.4
Management did not ensure internal audit findings were adequately corrected
Cited by Jesse A Vazquez
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 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aesthetic Group's 3 Form 483s
Source PDFs, verbatim observations, 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