FDA Inspection 1205700 — VCU Health System Reproductive Medicine and IVF
The FDA completed an inspection of VCU Health System Reproductive Medicine and IVF on May 12, 2023 in Richmond, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Richmond, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 3756 | 21 CFR 1270.35(a) | Results and interpretation of infectious disease tests |