FDA Inspection 1007440 — Aurora Health Care - Aurora Fertility Services
The FDA completed an inspection of Aurora Health Care - Aurora Fertility Services on Feb 13, 2017 in West Allis, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- West Allis, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |