FDA 483 - Life Line Stem Cell, Inc. - January 16, 2026

Life Line Stem Cell, Inc. in New Haven, IN, was cited for multiple deficiencies during an FDA inspection of its HCT/P recovery operations. Observations included the failure to clearly identify quarantined HCT/Ps, lack of established temperature limits for HCT/P storage, and inadequate documentation for the verification of supplies and reagents. The firm also failed to follow its own procedures for equipment calibration, specifically for temperature monitoring devices.