FDA Inspection 1156160 — Virginia Center For Reproductive Medicine
The FDA completed an inspection of Virginia Center For Reproductive Medicine on Oct 29, 2021 in Reston, VA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 29, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Reston, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |