FDA Inspection 963288 — Advanced Reproduction Institute, LLC
The FDA completed an inspection of Advanced Reproduction Institute, LLC on Mar 17, 2016 in Evansville, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Evansville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |