FDA Inspection 1310488 — Aesthetic Group
The FDA completed an inspection of Aesthetic Group on April 2, 2026 in Puiseux Le Hauberger. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Puiseux Le Hauberger (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 23076 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23225 | ISO 13485:2016 Clause 8.2.4 | Management did not ensure internal audit findings were adequately corrected |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |