FDA Inspection 1041521 — Indiana Organ Procurement Organization
The FDA completed an inspection of Indiana Organ Procurement Organization on February 20, 2018 in Indianapolis, 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
- February 20, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |