FDA Inspection
Matthew N. Songer, MDMatthew N. Songer, MD – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns Matthew N. Songer, MD, with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Matthew N. Songer, MD
- Inspection Date
- April 22, 2010
- Product Type
- Devices
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ID · 23fe6006-f60b-4b79-b7a1-d55134e35b8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 661026
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(b)(1)Statement of risks
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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Other FDA inspections of Matthew N. Songer, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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