FDA Inspection 756459 — Matthew N. Songer, MD
The FDA completed an inspection of Matthew N. Songer, MD on November 10, 2011 in Marquette, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Marquette, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |