FDA Inspection 568488 — University of Michigan Center for Reproductive Medicine
The FDA completed an inspection of University of Michigan Center for Reproductive Medicine on March 2, 2009 in Ann Arbor, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |