FDA Inspection
Advance-Esthetic LLCAdvance-Esthetic LLC – FDA Inspection, Feb 7, 2024
Record Details
This FDA Inspection record concerns Advance-Esthetic LLC, with an inspection on February 7, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c392872f-2220-44d3-97a4-307bac22ea0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228733
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 1040.10(f)(4)Key control
- 21 CFR 1002.13Failure to submit
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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 |
| March 15, 2022 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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