FDA Inspection
Solta Medical IncSolta Medical Inc – FDA Inspection, Jun 17, 2014
Record Details
This FDA Inspection record concerns Solta Medical Inc, with an inspection on June 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Solta Medical Inc
- Inspection Date
- June 17, 2014
- Product Type
- Devices
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ID · c701cf70-3477-4510-ae13-071a219c02e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 882308
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 812.43(c)(4)(ii)No supervision commitment in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.45Sponsor provide device information to investigators
- 21 CFR 50.20Exculpatory language, waiving of rights
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Other FDA inspections of Solta Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 17, 2012 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Solta Medical Inc
- FDA Inspection 873862 - 2014-04-10
- FDA Inspection 798415 - 2012-08-17
- FDA Inspection 755598 - 2011-12-02
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