FDA Inspection 773145 — Cleveland Clinic Fertility Center
The FDA completed an inspection of Cleveland Clinic Fertility Center on March 21, 2012 in Beachwood, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Beachwood, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |