FDA Inspection
Advantageous MD LlcAdvantageous MD Llc – FDA Inspection, Sep 12, 2011
Record Details
This FDA Inspection record concerns Advantageous MD Llc, with an inspection on September 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Advantageous MD Llc
- Inspection Date
- September 12, 2011
- Product Type
- Devices
View Company Profile
ID · e39c6140-293b-4bdf-954a-2bcb19a3c844
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 743827
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Advantageous MD Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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