FDA 483 - Americord Registry LLC - November 17, 2025

Americord Registry LLC, located in Somerset, New Jersey, underwent an FDA inspection from November 4 to November 17, 2025. The inspection focused on the facility"s handling of human tissue products, including umbilical cord blood, placental tissue, and exosomes. The FDA investigator identified seventeen major violations. Primary concerns included a significant failure to validate manufacturing processes, particularly for exosomes and microbiological testing methods. The firm also failed to establish and maintain adequate procedures for screening and testing tissue donors to ensure they are free from communicable diseases. In one instance, a cord blood unit was released for medical use without a documented determination of donor eligibility. Additional issues involved improper labeling, where products were shipped without necessary warning statements or with incorrect cryopreservation dates. The facility’s quality program was found lacking, as it failed to investigate positive contamination tests in both products and the laboratory environment. Furthermore, the inspection noted inadequate cleaning of sterile work areas and poor record-keeping regarding equipment sterilization and donor medical histories. These findings fall under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). While the FDA 483 is not a final legal determination, Americord Registry LLC is required to respond to these observations. The firm must provide a written plan detailing corrective actions taken or planned to address these deficiencies to ensure the safety and quality of their tissue products.