FDA Inspection 1148861 — University Fertility Laboratory, Inc.
The FDA completed an inspection of University Fertility Laboratory, Inc. on August 10, 2021 in Torrance, 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
- August 10, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |