# FDA 483 - Liveyon - September 21, 2018

Source: https://www.globalkeysolutions.net/records/483/liveyon/98e56818-e186-46c3-935f-6ef233e45d0b

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

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## Details

- Record Type: 483
- Company Name: Liveyon
- Inspection Date: 2018-09-21
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Liveyon, an own label stem cell distributor in Yorba Linda, CA, revealed serious deficiencies across its operations. The firm failed to report multiple fatal or life-threatening adverse reactions involving communicable diseases related to HCT/Ps. Significant issues were also noted in complaint handling, communicable disease testing interpretation, product release criteria, equipment calibration, HCT/P storage, and shipping conditions.

## Related Documents

- [483 - 2018-09-21](https://www.globalkeysolutions.net/records/483/liveyon/ba5efb70-906d-4ded-8666-5dc55a0df63a)
- [483 - 2019-05-23](https://www.globalkeysolutions.net/records/483/liveyon/0aa41747-5445-4f02-9ddf-15f7260d4837)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6