FDA Inspection 1057764 — Blue Sky Fertility Services LLC
The FDA completed an inspection of Blue Sky Fertility Services LLC on June 28, 2018 in Overland Park, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- 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 |