FDA Inspection 783195 — Corvus Medical, Inc.
The FDA completed an inspection of Corvus Medical, Inc. on May 22, 2012 in Spokane, WA. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Spokane, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |