FDA Inspection
Solta Medical IncSolta Medical Inc – FDA Inspection, Aug 17, 2012
Record Details
This FDA Inspection record concerns Solta Medical Inc, with an inspection on August 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Solta Medical Inc
- Inspection Date
- August 17, 2012
- Product Type
- Devices
View Company Profile
ID · 51e27f84-0f9e-4770-ba19-80de7fffd7a4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 798415
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 812.46(b)(1)No evaluation of unanticipated adverse effects
- 21 CFR 812.43(c)(4)(i)No investigation agreement statement of commitment
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.43(d)Monitors not qualified
- 21 CFR 812.43(a)Investigator(s) not qualified
- 21 CFR 812.140(b)(5)Sponsor records of adverse device effects & complaints
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
Showing 10 of 11 citations.
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Other FDA inspections of Solta Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Solta Medical Inc
- FDA Inspection 882308 - 2014-06-17
- FDA Inspection 873862 - 2014-04-10
- FDA Inspection 755598 - 2011-12-02
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