FDA Inspection 862534 — Overlake Reproductive Health Laboratory LLC
The FDA completed an inspection of Overlake Reproductive Health Laboratory LLC on January 17, 2014 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
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 |