FDA Inspection
Aesthetic GroupAesthetic Group – FDA Inspection, Apr 2, 2026
Record Details
This FDA Inspection record concerns Aesthetic Group, with an inspection on April 2, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 7676bcf0-8339-4af3-9fbb-8496ec2a957b
Inspection Facts
- Inspection number
- 1310488
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 6.3Requirements for infrastructure not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.2.4Management did not ensure internal audit findings were adequately corrected
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Aesthetic Group
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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