FDA Inspection 903435 — Reproductive Services Of Indiana, Inc
The FDA completed an inspection of Reproductive Services Of Indiana, Inc on November 5, 2014 in Carmel, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |