FDA Inspection 763041 — Froedtert Hospital Reproductive Medicine Center
The FDA completed an inspection of Froedtert Hospital Reproductive Medicine Center on Jan 11, 2012 in Menomonee Falls, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 11, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Menomonee Falls, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |