FDA Inspection 850739 — Gago Center for Fertility
The FDA completed an inspection of Gago Center for Fertility on September 30, 2013 in Brighton, MI. 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
- September 30, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brighton, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |