FDA Inspection 661026 — Matthew N. Songer, MD
The FDA completed an inspection of Matthew N. Songer, MD on April 22, 2010 in Marquette, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Marquette, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3064 | 21 CFR 812.140(a)(4) | Investigator protocol records inadequate |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |