FDA Inspection 1026748 — Overlake Reproductive Health Laboratory LLC
The FDA completed an inspection of Overlake Reproductive Health Laboratory LLC on September 27, 2017 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |