FDA 483 - Memorial Hospital For Cancer & Allied Diseases - May 29, 2019

Memorial Hospital For Cancer & Allied Diseases, a blood bank in New York, was inspected by the FDA from May 13-29, 2019. The inspection revealed significant deficiencies in record-keeping, adherence to standard operating procedures, failure to investigate product deviations, and untimely reporting of biological product deviations. These issues indicate a lack of robust quality control and compliance with regulatory requirements for blood and blood component processing and distribution.