FDA Inspection
Advance-Esthetic LLCAdvance-Esthetic LLC – FDA Inspection, Mar 15, 2022
Record Details
This FDA Inspection record concerns Advance-Esthetic LLC, with an inspection on March 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Advance-Esthetic LLC
- Inspection Date
- March 15, 2022
- Product Type
- Devices
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ID · e1cf6e55-9f36-446b-8b58-d616d4cd892e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1164672
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.10(h)(1)(iii)Legible reproductions
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Advance-Esthetic LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2025 | Not classified | Florida District Office | Compliance: Medical Devices |
| February 7, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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