FDA EIR - The Christ Hospital Health Network - March 15, 2022

The Christ Hospital Health Network underwent an FDA inspection on March 15, 2022, focusing on its hospital blood bank and human tissue distributor operations in Cincinnati, OH. The inspection was conducted under compliance program guidance manuals 7342.001 for "Blood and Blood Products" and 7341.002 for "Human Cells, Tissues, and Cellular and Tissued Based Products (HCT/Ps)." This was a level one inspection covering product testing, quality assurance, and product storage, quarantine, and disposition.

While no FDA Form 483, Inspectional Observations, was issued, a key discussion point emerged. The firm had gaps in temperature graphs for blood and tissue storage equipment on May 2, 2021, and lacked documented investigations to confirm that acceptable temperature levels were maintained during these periods, despite staff verbally confirming no alarms. Management acknowledged the observation and understood the importance of formal documentation for such investigations.

No formal regulatory actions were mandated due to the absence of an FDA Form 483, but the discussion highlighted the expectation for comprehensive record-keeping regarding critical environmental monitoring to ensure compliance and product integrity.