From January 16, 2019 to May 20, 2019, Liveyon Labs failed to thoroughly investigate 15 sterility failures and batches processed with cord blood units from ineligible donors: i. the kind that should due you in are the very opportunity area to be better than ever before to overcome. The exclusive video series streams live every Monday, Wednesday and Friday morning and featuresJohn Kosolcharoen, founder and chief executive officer of Liveyon and Dr. Alan Gaveck, director of education, Liveyon. The most recent email I sent to Kosolcharoen some months back did not receive a reply. They are also human cell, tissue, or cellular or tissue-based products (HCT/P) as defined in 21 CFR 1271.3(d)1 and are subject to regulation under 21 CFR Part 1271, issued under authority of section 361 of the PHS Act [42 U.S.C. Powered by Madgex Job Board Software. Your procedure fails to include a timeframe for complaint submission to QA by the Customer Service and Sales department or other Liveyon staff, potentially delaying QA notification and investigation. The root cause and source of the contaminating organisms was not identified. Not intended for diagnostic or therapeutic procedures.. Doctors and more specifically dermatologists? Treace Medical and Fusion Orthopedics have come to an agreement to resolve their legal dispute. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. DUH!!! Seriously. Authorities described the takedown as the largest in U.S. history, both in the number of those arrested and the financial scope of the fraud. Your firm did not implement corrective or preventive actions. In addition, you failed to track which batches have been processed (b)(4) potentially failing to identify contaminated umbilical cord blood product if one of the batches failed sterility or was processed using cord blood from an ineligible donor. Your complaint procedure LL-QA-015, entitled Product Complaint is not followed and is inadequate: a. The public? The CEO of Liveyon LLC, which is headquartered in Yorba Linda in Southern California, is a man named John W. Kosolcharoen. For example: a. Liveyon Labs failed to conduct surface and active air environmental monitoring from January 20 to February 16, 2019. That stem cell thrust ultimately landed a dozen or more people in the hospital as some of the product was somehow contaminated with bacteria along the way before injection in patients. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps. But Lois' connection to Liveyon doesn't end with her remarkable recovery, as she continues to be an integral support system for John as a CEO and for the company. For Lois, the next few years looked worrisome. In a way to me as a stem cell biologist this stem cell exosome cosmetics fluff stuff is not so different than iffy stem cell supplements out there and a host of stem cell creams (cremes?) Mother of Liveyon CEO Shares Heartfelt Stem Cell Success - BioSpace b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. /S/ For example, Liveyon Labs deficient donor eligibility practices, inadequate aseptic practices, and deficient environmental monitoring, as described below, pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects. This (b)(4) and (b)(4) are labeled For research use only.. In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). Join hosts, Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck, for this exclusive live podcast series, broadcast streaming live on the Liveyon Pure Cast podcast channel. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps. Complaint closure is also performed by the CCO of Liveyon LLC/Liveyon Labs instead of Liveyon Labs QA. The most recent email I sent to Kosolcharoen some months back did not receive a reply. What's the Difference? Umbilical Vs. Bone Marrow Stem Cells: Liveyon Stem cell clinic supplier Liveyon tries to regenerate - The Niche 4. very few actually found gold but the person who sold the tools to implement & extend each gold rushers intended plan were the actual winners financially overall. Simon Hong, 54, of Brea and his wife, Grace Hong, 50, who were arrested Monday and pleaded not guilty after being charged with billing Medicare for occupational therapy that was never provided at a facility they owned, JH Physical Therapy in Walnut. Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. While already suffering from severe arthritis, Lois tore her ACL/MCL meniscusleaving her not only with excruciating pain but the thought of being wheelchair-bound for the rest of her life. In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation. Karlton Watson You identified the contaminating organism(s) for your sterility failures but destroyed these batches without initiating/conducting an investigation using FORM-LL-037, entitled Positive Sterility or EM Failure-Root Cause Analysis. from 8 AM - 9 PM ET. 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]. This (b)(4) and (b)(4) are labeled For research use only.. You should take prompt action to correct these violations. Theyvare selling topical creams. You have my opinion here but does not take a rocket scientist to see zero future doing the right thing LIVEYON. Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]. Liveyon Joh Kosolcharoen is s complete fraudster ripping off people and making them sick!! And beyond all the science and the explanations, theres the story of the man behind it all.