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483
•Liveyon•September 21, 2018

Liveyon – FDA 483, Sep 21, 2018

Record Details

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.

Company
Liveyon
Inspection date
September 21, 2018
Product type
biologics
Office
Division of Pharmaceutical Quality Operations IV
People
  • Thanh B. Tran (Recall Coordinator)
  • Tania Y. Hall
View Company Profile

ID · 98e56818-e186-46c3-935f-6ef233e45d0b

Violation Codes3
21 U.S.C. 324(a)(4)21 CFR 331(c)FD&C Act 801(a)(3)

Full citation text and observation details available on the Dashboard.

Other documents for Liveyon
  • 483 - 2019-05-23May 23, 2019

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