862534
Overlake Reproductive Health Laboratory LLC — FEI 3004174071
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 17, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |