Tag

infections
Contaminated Umbilical Cord Blood

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Four

Over the past three posts (Part One, Part Two and Part Three) I have cited sections of 21 CFR 1271 as they relate to the manufacturing of HCT/Ps, such as cord blood-derived products produced by Genetech and sold by Liveyon that resulted in 15 patients (so far) suffering often severe adverse events due to having...
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Liveyon Blames FDA

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Three

In the past two posts (Part One and Part Two) I have covered details about a serious lapse in quality control on the part of Genetech, the source of contaminated cord blood-derived products, which was injected into 15 patients who have developed serious infections, as tracked by the CDC. Genetech sold the donor-derived cord blood...
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Genetech Failure

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Two

In the previous post, I had begun to review the Warning Letter the FDA issued to Genetech, who was the supplier of cord blood-derived products to Liveyon, who in turn sold the contaminated vials of their product to physicians across the USA. While the most shocking observation the FDA made in the Warning Letter was...
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Genetech Provides Contaminated Donor-Derived Therapy

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part One

Recently, the CDC announced to the public the existence of an outbreak of infected patients who had received a donor-derived regenerative therapy in several states: “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.” It isn’t a...
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