FDA Inspection 1078946 — University Fertility Laboratory, Inc.
The FDA completed an inspection of University Fertility Laboratory, Inc. on Feb 4, 2019 in Torrance, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 4, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |