904809
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- The Woodlands, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2995 | 21 CFR 812.140(b)(4) | Availability of records of non-significant risk studies |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |