FDA Inspection 1111968 — University Fertility Laboratory, Inc.
The FDA completed an inspection of University Fertility Laboratory, Inc. on November 26, 2019 in Torrance, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 26, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12235 | 21 CFR 1271.55(a)(1) | Personal information included in I.D. code |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |