FDA Inspection 1198722 — Loma Linda University Center for Fertility and IVF
The FDA completed an inspection of Loma Linda University Center for Fertility and IVF on March 2, 2023 in Loma Linda, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Loma Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |