FDA Inspection 954292 — Froedtert Hospital Reproductive Medicine Center
The FDA completed an inspection of Froedtert Hospital Reproductive Medicine Center on December 8, 2015 in Menomonee Falls, WI. 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
- December 8, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Menomonee Falls, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |