FDA 483 - BHC, LLC - June 30, 2023

BHC, LLC, an HCT/P processor and distributor in Brownsburg, IN, was cited for significant deficiencies related to donor eligibility, product labeling, and procedural controls during an FDA inspection. Observations included failures to properly determine donor eligibility, document physician notifications for ineligible donors, label biohazardous products, and establish adequate procedures for donor testing and product release. These issues indicate a lack of robust quality controls for human umbilical cord blood products.