FDA Inspection 1256959 — Medical City Plano IRB
The FDA completed an inspection of Medical City Plano IRB on Dec 6, 2024 in Plano, TX. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Plano, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |