FDA Inspection 643684 — Community Blood Center
The FDA completed an inspection of Community Blood Center on February 5, 2010 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12257 | 21 CFR 1271.60(c)(2) | Records stating determination not completed |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |