FDA Inspection 726921 — Seattle Sperm Bank LLC
The FDA completed an inspection of Seattle Sperm Bank LLC on May 24, 2011 in Seattle, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 24, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12255 | 21 CFR 1271.60(c) | Shipped but not kept in quarantine |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |