FDA Inspection 629005 — Liberty IRB, Inc.
The FDA completed an inspection of Liberty IRB, Inc. on Oct 1, 2009 in Deland, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 1, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Deland, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |