FDA Inspection 587399 — Sperm Bank, Inc
The FDA completed an inspection of Sperm Bank, Inc on June 12, 2009 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12245 | 21 CFR 1271.55(d)(1)(ii) | Results, interpretation of CD screening |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |