FDA Inspection
Advanced Aesthetic Concepts LP d/b/a/ ProfitSolutions MDAdvanced Aesthetic Concepts LP d/b/a/ ProfitSolutions MD – FDA Inspection, Oct 16, 2012
Record Details
This FDA Inspection record concerns Advanced Aesthetic Concepts LP d/b/a/ ProfitSolutions MD, with an inspection on October 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2012
- Product Type
- Devices
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ID · 55ece1ce-7e24-411f-9675-53cd3528a0b0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
20- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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