721842
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- The Woodlands, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3063 | 21 CFR 812.140(a)(3)(iii) | Investigator records of exposure to device inadequate |