FDA Inspection 1224904 — Los Angeles Reproductive Center
The FDA completed an inspection of Los Angeles Reproductive Center on Dec 12, 2023 in Encino, CA. 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 12, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Encino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |