FDA Inspection 972332 — Community Fertility Specialty Care
The FDA completed an inspection of Community Fertility Specialty Care on May 5, 2016 in Indianapolis, IN. 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
- May 5, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |