FDA Inspection 907429 — Olympia Women's Health
The FDA completed an inspection of Olympia Women's Health on December 16, 2014 in Olympia, 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
- December 16, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Olympia, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |