FDA 483 - Cedars-Sinai Medical Center - August 26, 2022

During an FDA inspection from August 15-26, 2022, Cedars-Sinai Medical Center, a blood bank located at 8700 Beverly Blvd, Los Angeles, CA, received a Form 483 with seven observations.

**Observation 1:** The firm failed to conduct thorough investigations, document conclusions, and follow up on unexplained discrepancies and failures to meet specifications since 2018. This includes trends of employees failing to verify donor information (e.g., overdraw of plasma due to incorrect weight, ineligible plasma donation) and donor identity after screening (e.g., incorrect unit labels, documentation errors across multiple donors). Several instances involved incorrect data entry into the blood establishment computer software (BECS) that required vendor intervention to resolve.

**Observation 2:** Donor records were not adequately maintained, and electronic records did not meet requirements for trustworthiness and reliability. Specifically, the electronic blood information system did not always accurately reflect donor screening information, as only the final hemoglobin test result was documented in BECS, not the initial or repeated tests, despite written procedures allowing for retesting.

**Observation 3:** The firm failed to make reasonable attempts to notify donors deferred due to positive/reactive relevant transfusion-transmitted infection (RTTI) test results. From 2020 to 2022, only a single unregistered letter was sent, with no documentation of receipt or further contact attempts for deferred donors.