FDA Inspection 677923 — The Fertility Center Of Oregon
The FDA completed an inspection of The Fertility Center Of Oregon on Jul 23, 2010 in Eugene, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 23, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Eugene, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |