FDA Inspection 916538 — The Fertility Center of Oregon
The FDA completed an inspection of The Fertility Center of Oregon on February 20, 2015 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
- February 20, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Eugene, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |