FDA Inspection 1237925 — Ossium Health Inc
The FDA completed an inspection of Ossium Health Inc on May 30, 2024 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 30, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12389 | 21 CFR 1271.220(c) | Specified requirements for in-process controls |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |