Sibley Memorial Hospital – FDA Warning Letter, Sep 18, 2009

On December 15, 2009, the FDA issued a Warning Letter to Sibley Memorial Hospital following an inspection from September 14-18, 2009. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for blood and blood products (21 CFR Parts 600-680), rendering their products adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to notify transfusion recipients of positive supplemental test results (21 CFR 610.47(b)(3)):** A recipient of a unit transfused in 1998 was not notified of the donor's subsequent positive HCV supplemental test result, discovered only during the FDA inspection. 2. **Failure to maintain complete and traceable records (21 CFR 606.160):** Records for blood components sent for irradiation lacked details such as shipment/return dates/times, RadSure label inspection, and conversion to irradiated status. 3. **Failure to review records and investigate discrepancies (21 CFR 606.100(c)):** Irradiation logs and electronic records were incomplete/inconsistent and not reviewed before product release. Additionally, five instances of failure to perform antigen typing lacked documented investigations, conclusions, or follow-up. 4. **Failure to