FDA Inspection 791237 — Oregon Fertility Institute, LLC
The FDA completed an inspection of Oregon Fertility Institute, LLC on July 19, 2012 in Portland, OR. 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
- July 19, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12385 | 21 CFR 1271.150(c)(2) | Responsibility for review before distribution |