FDA 483 - Liveyon - September 21, 2018

The FDA Form 483 documents multiple violations related to the handling and reporting of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

**Facility and Operation Details:** The document details issues with a facility distributing HCT/Ps, including a contract manufacturer.

**Violations and Observations:** * **Adverse Event Reporting:** Multiple adverse reactions involving communicable diseases (e.g., Graft vs. Host Disease, E. Coli infections) were not reported to the FDA, despite being fatal, life-threatening, causing permanent impairment, or necessitating medical/surgical intervention. Specific instances include AER-022018-01, AER-022018-02, AER-080218-01, AER-080218-02, AER-080218-03, AER-081718-01, and AER-090418-01, all detailing patient hospitalizations, surgeries, and positive lab cultures. * **Complaint Handling:** Complaint records were deficient, lacking investigation findings and follow-up. Instances where no further investigation was deemed necessary were not documented. Complaint 61818-01, involving an ER visit and E. Coli, was not followed up. Several complaints (081018-01,