FDA Inspection 602306 — Olympia Women's Health
The FDA completed an inspection of Olympia Women's Health on August 5, 2009 in Olympia, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Olympia, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |