# FDA 483 - Liveyon - September 21, 2018

Source: https://www.keypedia.com/records/483/liveyon/ba5efb70-906d-4ded-8666-5dc55a0df63a

> FDA 483 for Liveyon on September 21, 2018. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Liveyon
- Inspection Date: 2018-09-21
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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,

## Related Documents

- [483 - 2018-09-21](https://www.keypedia.com/records/483/liveyon/98e56818-e186-46c3-935f-6ef233e45d0b)
- [483 - 2019-05-23](https://www.keypedia.com/records/483/liveyon/0aa41747-5445-4f02-9ddf-15f7260d4837)

## Related Officers

- [Recall Coordinator](https://www.keypedia.com/people/thanh-b-tran/19f057a0-bb62-4d05-b79c-073e24be6480)
- [Tania Y. Hall](https://www.keypedia.com/people/tania-y-hall/94f342b2-a5f3-4ff1-ae5a-7f75fefe2214)

Company: https://www.keypedia.com/companies/liveyon/668e46df-24a9-4a18-baf6-9d0752315ec0

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b