Cleveland Clinic – FDA EIR, Apr 3, 2013

An FDA inspection was conducted at Cleveland Clinic Foundation in Cleveland, OH, spanning from March 27, 2013, to April 3, 2013. The inspection evaluated the facility's adherence to regulatory standards governing the handling and processing of blood components. The primary issues identified during the inspection centered on deficiencies in procedural compliance and record-keeping practices. Specific observations included inadequacies in the Document Integrity procedure, discrepancies in Irradiation Records for Blood Components, and failures to consistently follow the Emergency Release of Blood Components procedure. Further concerns were noted regarding the completeness and accuracy of Emergency Blood Product Release Requests, specifically concerning missing initials and dates signed, as well as an instance of improper modification to an irradiation record. These findings led to the issuance of an FDA-483, detailing inspectional observations that necessitate corrective actions to ensure compliance with federal regulations for blood establishments. Cleveland Clinic Foundation has submitted a preliminary plan to address these findings and restore compliance.