FDA Inspection 710134 — Centra Health Inc IRB
The FDA completed an inspection of Centra Health Inc IRB on February 15, 2011 in Lynchburg, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 15, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lynchburg, VA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2826 | 21 CFR 113.40(g)(1)(ii)(A) | Startup - commercial sterility |
| 2843 | 21 CFR 113.40(g)(1)(i)(A)(5) | TID not reference instrument |
| 2844 | 21 CFR 113.40(g)(1)(i)(B) | Present each sterilizer, accurate |
| 2848 | 21 CFR 113.40(g)(1)(i)(B)(3) | Adjusted to agree with TID |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7298 | 21 CFR 56.109(a) | Authority of the IRB |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7405 | 21 CFR 56.109(f) | Authority to observe consent process and research |