FDA Inspection 1057764 — Blue Sky Fertility Services LLC
The FDA completed an inspection of Blue Sky Fertility Services LLC on Jun 28, 2018 in Overland Park, KS. 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
- Jun 28, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Overland Park, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |