FDA WARNING_LETTER - The Children's Hospital Assoc. Transfusion Medicine Services - February 10, 2010

The FDA inspected The Children's Hospital Association Transfusion Medicine Services from January 13 to February 10, 2010, and found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for blood and blood products (21 CFR Parts 210-211 and 600-680), rendering products adulterated under 21 USC 351(a)(2)(B).

Violations included: 1. **Failure to defer donors testing reactive for communicable disease agents (21 CFR 610.41(a))**: Examples cited two donors with repeat reactive anti-HCV tests whose statuses were incorrectly changed to "Active" without proper requalification. 2. **Failure to maintain records identifying unsuitable donors (21 CFR 606.160(e))**: Issues included duplicate donor records with conflicting deferral statuses, a deferred donor for a tattoo remaining "Active" due to missing defer-to-date, and a permanently deferred donor for travel remaining "Active." 3. **Improper storage of Whole Blood (21 CFR 640.4(h))**: Whole Blood units from mobile sites were stored at room temperature for up to 7.5 hours before transport, exceeding the required continuous cooling toward 1-10°C. 4. **Inadequate controls over computer systems (21 CFR