Puget Sound Blood Center and Program – FDA Warning Letter, Feb 15, 2013

On January 14 - February 15, 2013, the FDA inspected Puget Sound Blood Center (PSBC) and found significant deviations from cGMP regulations (21 CFR Parts 606, 610, 640, and 211), causing blood products to be adulterated.

Violations include: 1. **Inadequate Complaint Investigations (21 CFR 211.198(b)(2))**: Complaint records lacked investigation findings and follow-up. Examples include a Red Blood Cell unit with "greenish clots" redistributed without documented investigation, and a "Blood Unit Visual Inspection" alert for a Red Blood Cell unit lacking documented follow-up. 2. **Failure to Take Corrective Action for Quality Control Failures (21 CFR 640.25(b)(4))**: Leukoreduced Platelet products consistently failed to meet yield and recovery standards. Monthly QC targets for platelet yield were rarely met, and post-filtration recovery targets were not met since May 2010. Prior occurrences were closed despite ongoing failures, and no investigation was conducted into current failures after a filter change in August 2010. 3. **Unauthorized Use of Alternative Procedures (21 CFR 640.120(a))**: PSBC used a filtration system for Platelets in a manner inconsistent with manufacturer instructions (for leukore