FDA Inspection 654606 — Center for Reproductive Medicine
The FDA completed an inspection of Center for Reproductive Medicine on March 16, 2010 in Minneapolis, MN. 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
- March 16, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |