FDA Inspection 854710 — Olympia Women's Health
The FDA completed an inspection of Olympia Women's Health on October 29, 2013 in Olympia, 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
- October 29, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Olympia, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12254 | 21 CFR 1271.60(b) | Identified as quarantined, distinguishable |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |