FDA Inspection 755444 — The Fertility Center of Oregon
The FDA completed an inspection of The Fertility Center of Oregon on November 17, 2011 in Eugene, OR. 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
- November 17, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Eugene, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |