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As noted above and in the FDA Warning Letter issued on November 29, 2018, to your former contract manufacturer Genetech, Inc. with a copy to Liveyon LLC and Mr. Kosolcharoen, to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. In order to market them in a compliant way you must have prior FDA approval. because they were burned before in this unfortunate incidence of fall of 2018 brought but they did not die. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. Opinions expressed by Forbes Contributors are their own. If you go to their exosome website here, you can see all the typical Liveyon style of partially-nude young women splashed all over the place interspersed with marketing for the new Luma exosome product. Their leader John Kosolcharoen? Its all about informed consent but people arent getting it, she says. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? The root cause and source of the contaminating organisms was not identified. They are in it for a quick buck. We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations and prevent their recurrence. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications, [21 CFR 211.192]. and Buffalo Bone and Joint, PLLC have filed a $24.7 million lawsuit. Liveyon spent a million dollars on a commercial seminar for doctors who were pitched on how much money they could make and then given a script of exactly what to say to patients. Not exactly. The DT-001 Form 1 Recovery Site Assessment received from cord blood supplier (b)(4) did not adequately assess a donors residence in, or travel to, areas identified by the Centers for Disease Control and Prevention with active ZIKV transmission. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. I call it an unheard of A+++ endorsement as of last May 2019 . Also, a man named John W. Kosolcharoen, who at the time lived in Rancho Margarita, 22.3 miles down the I-5 interstate from Yorba Linda, agreed to be banned from selling securities in October 2014 after the Securities and Exchange Commission accused him of being the lead salesman for a massive securities Ponzi scheme in Southern California.