FDA Inspection 754501 — Center For Reproductive Biology Of Indiana, LLC
The FDA completed an inspection of Center For Reproductive Biology Of Indiana, LLC on November 21, 2011 in Carmel, IN. 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
- November 21, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12275 | 21 CFR 1271.65(c) | Nonclinical use--label requirements |