FDA Inspection 654524 — Henry Ford Center for Reproductive Medicine
The FDA completed an inspection of Henry Ford Center for Reproductive Medicine on March 25, 2010 in Rochester Hills, MI. 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
- March 25, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |