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FDA Inspection
•Advance-Esthetic LLC•November 6, 2025

Advance-Esthetic LLC – FDA Inspection, Nov 6, 2025

Record Details

This FDA Inspection record concerns Advance-Esthetic LLC, with an inspection on November 6, 2025, issued by the Florida District Office, covering medical devices & rad health.

Company
Advance-Esthetic LLC
Inspection Date
November 6, 2025
Product Type
Medical Devices & Rad Health
Office
Florida District Office
Person
  • Monica C. Burgos Garcia
View Company Profile

ID · 53c8c78a-ae07-4e2a-8270-1fee29bc53a3

Inspection Facts

Inspection number
1280825
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 1002.13Failure to submit
  2. 21 CFR 1003.10(a)FDA not notified of defect or noncompliance
  3. 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
  4. 21 CFR 820.100(a)Lack of or inadequate procedures
  5. 21 CFR 820.198(b)Review and evaluation for investigation
  6. 21 CFR 820.50(b)Approval, inadequate purchasing data

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advance-Esthetic LLC

2
DateClassificationOfficeProject area
February 7, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
March 15, 2022OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Advance-Esthetic LLC
  • FDA Inspection 1228733 - 2024-02-07
  • FDA Inspection 1164672 - 2022-03-15

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