FDA Inspection 1097832 — Steelhead Surgical, Inc. Boise
The FDA completed an inspection of Steelhead Surgical, Inc. Boise on Jul 12, 2019 in Boise, ID. 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
- Jul 12, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |