FDA Inspection 1219185 — Sperm Bank, Inc.
The FDA completed an inspection of Sperm Bank, Inc. on Sep 29, 2023 in Tustin, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |