FDA 483 - Morristown Medical Center Blood Bank - November 19, 2024

An FDA inspection of Morristown Medical Center Blood Bank in Morristown, NJ, revealed significant deficiencies in their operations. Observations included failures to establish and follow written standard operating procedures for blood and blood component processing, leading to inadequate documentation of critical tasks. Additionally, records were found to be incomplete, lacking essential details such as the person performing the work, dates of entries, and supervisory reviews, hindering the ability to trace the complete history of work performed.