FDA Inspection 1069377 — Shady Grove Reproductive Science Center PC
The FDA completed an inspection of Shady Grove Reproductive Science Center PC on Oct 18, 2018 in Leesburg, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 18, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Leesburg, 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 |