FDA 483 - Cardinal Biologicals, Inc. - May 09, 2025

Cardinal Biologicals, Inc. in Cape Girardeau, MO, an HCT/P establishment, was cited for six observations during an FDA inspection. The findings primarily concern inadequate record-keeping for equipment use and cleaning, lack of environmental monitoring, and improper handling and labeling of human birth tissues, particularly those pending donor eligibility. These issues indicate a failure to prevent contamination and ensure product safety.