Advance-esthetic Llc
4101 Ravenswood Rd Ste 110, Fort Lauderdale, FL, US
Registered product codes
10 product codes
Recent MDR events
4 on file
Compliance history
Matched by FEI 3013397886.
FDA inspections
3 on file
- Voluntary Action Indicated (VAI)Feb 7, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 7, 2024
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 7, 2024
Radiation Control and Health Safety Act · Citations posted
Inspection citations
15 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
1
- 21 CFR 820.20(c)Feb 7, 2024
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Feb 7, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Feb 7, 2024
Training - Lack of or inadequate procedures
- 21 CFR 820.40Feb 7, 2024
Procedures not adequately established or maintained
- 21 CFR 820.50Feb 7, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Feb 7, 2024
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(a)Feb 7, 2024
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Feb 7, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 7, 2024
Lack of or inadequate procedures
- 21 CFR 820.181Feb 7, 2024
DMR - not or inadequately maintained
- 21 CFR 820.184Feb 7, 2024
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Feb 7, 2024
Lack of or inadequate complaint procedures
- 21 CFR 1002.13Feb 7, 2024
Failure to submit
- 21 CFR 1005.3Feb 7, 2024
Lack of certification
- 21 CFR 1040.10(f)(4)Feb 7, 2024
Key control
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.