FDA Inspection 734391 — Harborview Medical Center
The FDA completed an inspection of Harborview Medical Center on July 8, 2011 in Seattle, WA. 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
- July 8, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |