FDA Inspection 1030777 — Loma Linda University Center for Fertility and IVF
The FDA completed an inspection of Loma Linda University Center for Fertility and IVF on November 3, 2017 in Loma Linda, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 3, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Loma Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |