Therefore, your products are not regulated solely under section 361 of the PHS Act [42 U.S.C. To stay up-to-date on the regenerative medicine industry and receive notices of free upcoming live streaming video events, please subscribe to 'Liveyon Pure-Cast. Additionally, 1+ was inaccurately recorded as 1 CFU in the Positive Sterility and EM Log. DUH!!! Insiders Provide Real Solutions to the Tough Problems Plaguing the Industry. 3. Theyve thrown the buzz phrase nanoparticles in there too. Such licenses are issued only after showing that the product is safe, pure, and potent. Of course, for approved biological products, the standard is safe, pure and potent, not relatively safe, pure and potent. But even the standard for 361 HCT/Ps is more rigorous than relatively safe, as the statutory requirement is the prevention of the introduction, transmission or spread of communicable disease, he added. https://www.justice.gov/opa/file/869161/download, {Kurt Frank says: LIVEYON could not monitor GENETECH (3rd party mfg 24/7 and trusted NOT to have to medically speaking) As all companies cannot monitor the QC of the third party mfg as you have to have a level of trust that ethically that they are keeping the agreed contractual formulation day to date . from 8 AM - 9 PM ET. According to state medical board records, Albert has been disciplined twice, most recently in 2005 for gross negligence after charging a workers comp patient for services already covered by her insurer. The root cause and source of the contaminating organisms was not identified. This is the Wild West west of regenerative medicine but this did not get LIVEYON to give up . 3. They started selling another in-house produced product. 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. Weekly reads: Sarepta, epigenomics, FDA on eyedrops, Top 50 stem cell influencers to follow on Twitter, List of FDA Approved Stem Cell Therapies & Drugs, Fact-checking stem cell supplements in 2023, What is PRP injection cost, risks, & possible benefits. Liveyon's continuing metamorphosis A screenshot from the Liveyon Luma exosomes website. 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. She's strong in her own right: in her twenties, she was one of the first women to operate a crane at the Dow Chemical plant in Lake Jackson. On the new website they are introducing their new Luma Restore Exosome line. The deviations in manufacturing processes observed as well as those noted in documents collected during the inspection indicate that the use of your products raises potential significant safety concerns. Doctors and more specifically dermatologists? The deficiencies include, but are not limited to, the following: 1. more and more 24/7. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. Induced pluripotent stem cells or IPS cells. The podcast provides a complimentary resource for clients of the company's new product line. LIVEYON from day one in industry was already building their own lab (kitchen) because they did not like having third party mfg constraints yet never thought GENETECH would ever secretly cut agreed contractual corners. Treace Medical and Fusion Orthopedics have come to an agreement to resolve their legal dispute. Based on this information, we have determined that your actions have violated the FD&C Act and the PHS Act. c. From February 9 to February 13, 2019, Liveyon Labs used contact (b)(4) plates as settling (b)(4) plates to monitor the BSCs during each fill when your firm no longer had any settling plates in stock. Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. This (b)(4) and (b)(4) are labeled For research use only.. Their ads for patients were like siren songs that caused people to want to believe that its going to work and that belief creates a placebo effect. It was the responsibility of LIVEYON to ensure that the products they purchase for use in processing to manufacture products intended to treat a variety of orthopedic conditions meet FDA standards for safety and efficacy. iii. We dont see too many people defending this firm. Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. The number of colonies were not counted if greater than 1 and marked as 1+. This practice, which you refer to as (b)(4) processing, is considered high risk and significantly increases the potential for cross-contamination and mislabeling. 262(a)(3); 21 CFR Part 312]. 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]. An anonymous former employee confirms, the lack of care and effort towards ethical treatment of products and employees is astounding. Many successful companies have alot to overcome at certain points but its those very AMERICAN failure issues . Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 CFR 211.113(b)]. Complaint C-19-003 was received on March 7, 2019, forwarded to QA on the same day, and QA did not commence their investigation until May 1, 2019. Get Phone Number. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. Ya kinda of think Genetech either planted it or simply got sloppy with greed because they knew LIVEYON was building their own lab which would have been done late fall or early winter of this coincidental timing so their exclusive payday was obviously ending after a second year contract as originally contracting GENETECH MFG was only till LIVEYONs own lab was complete. In all, 22 defendants face federal charges in Santa Ana and Los Angeles as part of a nationwide sweep involving 301 people accused of falsely billing $900 million, the U.S. attorneys office said. Yorba Linda, CA 92887 355(i); 42 U.S.C. The way I see it is simple . arrested in nationwide health fraud sweep, Whats new: Loma Villas apartments sell for $21.5M to investor, 4 dead in Mojave Desert community after shooting report, El Chapo sons send Mexico cartels cheap fentanyl into US, Sacramento Snapshot: Cities would need to include homeless-serving housing in state plans under new bill, Orange County restaurants shut down by health inspectors (April 20-27), More land sliding at Casa Romantica; residents evacuated, trains halted through San Clemente, Orange County Artist of the Year winners announced, Then and Now: Photos of Casa Romantica show damage caused by landside, Fire at Barnes & Noble in Orange disrupts book-signing event, OC Marine who volunteered in Ukraine, survived rocket attack: I would do it again, The DMV says permission to drive is based on ability, but older drivers are scrutinized more, Cold, drizzly week ahead for Southern California, A look at Orange Countys baseball teams and the CIF-SS playoffs, Joe Bidens re-election bid is off to a bad start, Do Not Sell/Share My Personal Information. "I said 'I have the least amount to lose, I'm the oldest and I believe this product is 100 percent pure,'" Lois recalled on the podcast. For example: i. Founded in 2016, Liveyon is pushing the boundaries of regenerative medicine with its innovative take on product research and development, manufacturing and distribution, and commitment to safety and transparency. arrested in nationwide health, Click to share on Facebook (Opens in new window), Click to share on Twitter (Opens in new window), Click to share on Reddit (Opens in new window), Seven from O.C. That website and video was made in 2017. A new film-commercial entitled Awakening pitches unproven exosomes and has already been possibly tied to the troubled stem cell supplier firm Liveyon, but now it seems that the links go far deeper including a possible relative of Liveyon leader John Kosolcharoen.. agreed to be banned from selling securities, https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm488582.pdf, Orthopedic Surgeon Sues NY Health System for $24.7M, Ortho Surgeon Whistleblowers Sue Erlanger Health System, Treace Medical Concepts and Fusion Orthopedics Reach Settlement, 510(k) Clearance for Femur Fracture Fixation Nailing System, 510(k) Clearance for Web-Based Orthopedic Planning Solution, Conformis and Bodycad Settle Patent Dispute, Welcome to our Master Class on Lumbar Total Joint Replacement, History of the Fernstrom Ball, BAK and Spine-Tech, 4WEB Sues NuVasive for Alleged Patent Infringement, 5,153 Patient THA Study Finds 2.8x Revision Racial Disparity, SurgiSTUD: A New Gold Standard for Surgical Training, One Consistently Top Ranked Spine Meeting. Really Paul? Please be advised that to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. The first four episodes of Bad Batch are available now or you can sign up for Wondery Plus and listen to the episodes ad-free. Liveyon is back (again) with unproven exosome product 'Is There A Stem Cell Bubble?' Liveyon CEO, Education - BioSpace The CEO of Liveyon LLC, which is headquartered in Yorba Linda in Southern California, is a man named John W. Kosolcharoen. (b)(4) vials were distributed without any environmental monitoring data demonstrating control of the immediate manufacturing environment. 'Is There A Stem Cell Bubble?' Liveyon CEO, Education - Insider 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]. Orthopedics Spine Surgeon or Neurosurgeon, Is There a Difference? 6. The DT-001 Form 4 Donor Risk Assessment Interview received from cord blood supplier (b)(4) did not indicate if the donor has been diagnosed with Creutzfeldt-Jacob disease (CJD) or variant Creutzfeldt-Jacob disease (vCJD). FDA has granted 510(k) clearance to a trochanteric nailing system from X-Bolt Orthopedics. Liveyon does NOT distribute or provide "stem-cells"!! The company's dynamic ability to adapt to changing market trends and execute on opportunities has fortified its exponentialgrowth and the company is poised to continue making a huge impact in the industry 2019. http://www.prnewswire.com/news-releases/mother-of-liveyon-ceo-shares-heartfelt-stem-cell-success-story-with-son-on-pure-cast-podcast-300827743.html. The more you pay for something the stronger the placebo effect is., Hernan Lopez, the CEO of Wondery, was at the Q and A and asked Laura, Should the fact that the treatments are cash only be a red flag?, Yes!, Laura responded, but there are patients that have the idea that medical research is too slow. The CFUs for lot number (b)(6) were noted as too numerous to count (TNTC) in the raw environmental monitoring data, however it was recorded officially as 1+ CFUs in the In-Process EM Data and 1 CFU in the Positive Sterility and EM Log. Host and researcher Laura Beil expanded the basic news story to look at the science and regulation behind stem cells and explain it in an easy to understand way. In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation. For example: a. This is not an accurate statement. During this time period, your firm did not fail or destroy two batches manufactured on the same day due to positive sterility or infectious disease testing results. 2. 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. The main reason that any of this happened, according to Beil, is that stem cells are not treated as drugs and the FDAs attitude is that its not a drug to regulate since youre just moving parts of your own body around. Its all about informed consent but people arent getting it, she says. 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. This is obviously a smear campaign. Liveyon product hurt many more patients says new CDC study Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. ii. Ive been writing about medicine for 25 years, Laura says, and the placebo effect is powerful. He has signed a plea agreement stemming from allegations that he billed workers comp for $4.2 million between 2008 and 2014 from fraudulent patient reports based on templates with copied and pasted information. Some had sepsis and ended up in the ICU. John K, as hes referred to in the podcast, was more than happy to talk to her because he did not see himself as the villain, which made the story more complicated. Liveyon Reviews 3.1 44 % Recommend to a Friend 44 % Approve of CEO John W. Kosolcharoen 5 Ratings 5.0 Current Employee, less than 1 year "Great" Nov 26, 2021 - Sales Associate Recommends Positive Outlook Approves of CEO Pros Great place to work and Cons There aren't any cons love it Advice to Management Keep up the good work Clearly LIVEYON was running a very dangerous, illegal and unethical snake oil shop. Run from this company. Geez. Those from Orange County charged and arrested Tuesday in the pharmacy cases are: John Garbino, 46, of Dana Point, charged with receiving illegal kickbacks after his marketing business referred prescriptions to compounding pharmacies who then paid him as much as 65 percent of the reimbursement. Therefore, review of relevant medical records, as defined in 21 CFR 1271.3(s), must indicate that a potential donor is free from risk factors for, or clinical evidence of, ZIKV infection for the purpose of determining donor eligibility. Not exactly. Powered by Madgex Job Board Software. LIVEYON has risen from the very flame that tried to extinguish its exceptional reputation and purest product (non manipulated) UCB stem formulation that no other company to date has accomplished. Mother of Liveyon CEO Shares Heartfelt Stem Cell Success Story with Son 'Is There A Stem Cell Bubble?' Liveyon CEO, Education Director Discuss Most of the Southern California cases stemmed from a compounding pharmacy scheme targeting TRICARE. Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)]. In fact, if you read their clinical support closely and do a little homework, you will understand the gimmick. They are in it for a quick buck. Liveyon and Liveyon Labs Inc. are committed to achieving unparalleled stem cell potency through high live nucleated cell counts, while following validation protocols that produce an extremely consistent product for the most efficacious outcomes. Dynamic Digital Radiography Better for Shoulder Injuries, Orthopedists Happiness Declined After Pandemic. [Suppling food, equip, tools, explosives, etc., etc{ to help the guy Work/ extend / live his/her dream as they choose. Liveyon CEO John W. Kosolcharoen believes that while the stem cell industry has made impressive strides in recent years, a key element in advancing regenerative applications for cord blood. They also say the product is acellular, so I guess they are forging ahead without a stem cell focus, at least with Luma? My guess is that FDA is keeping very close tabs on the perinatal space these days. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. YORBA LINDA, Calif., April 9, 2019 /PRNewswire/ -- In a recent episode of the Liveyon 'Pure-Cast,' John Kosolcharoen, founder and CEO of Liveyon, and Dr. Alan Gaveck, Director of Education, examined the state of the regenerative industrybreaking down some of the most pressing problems plaquing the stem cell field and offering real solutions. FDA acknowledges Liveyon Labs decision to cease the receipt of umbilical cord blood from (b)(4), located in (b)(4). Maybe, maybe not. Not intended for diagnostic or therapeutic procedures.. A John W. Kosolcharoen, who at the time lived in Santa Ana, 12.3 miles from Yorba Linda, was arrested June 20, 2016 after a lengthy FBI investigation. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. Before sharing sensitive information, make sure you're on a federal government site. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. 'Miraculous' stem cell therapy has sickened people in five states The ultimate podcast show featuring hosts, Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck, discussing Liveyon's new product offerings and the most controversial, popular and relevant stem cell regenerative medicine topics. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? Espaol. Please check your inbox or spam folder now to confirm your subscription. The medical board alleged at the time that she had engaged in many instances of prescribing HGH for improper purposes. Here are some of the FDA findings when they inspected LIVEYON: At the close of the inspection, FDA investigators issued a Form FDA 483 to Erin M. Sairafe, Chief Compliance Officer for both Liveyon Labs and Liveyon LLC, listing inspectional observations, which described a number of significant deviations from CGMP and CGTP. "Within a month or six weeks, I was walking pain-free two to three miles a day, and it just increased from there," Lois said. In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). The most recent email I sent to Kosolcharoen some months back did not receive a reply. Even so, Kosolcharoen (pictured with another Liveyon leader Alan Gaveck below in a web video) recently denied involvement in an . b. What's the Difference? Umbilical Vs. Bone Marrow Stem Cells: Liveyon All rights reserved. Find John Kosolcharoen's accurate email address and contact/phone number in Adapt.io. The company's dynamic ability to adapt to changing market trends and execute on opportunities has fortified its exponentialgrowth and the company is poised to continue making a huge impact in the industry 2019. A stem cell treatment returned his mother to good health. 22667 Old Canal Road 212429@email4pr.com, View original content to download multimedia:http://www.prnewswire.com/news-releases/mother-of-liveyon-ceo-shares-heartfelt-stem-cell-success-story-with-son-on-pure-cast-podcast-300827743.html, 1985 - 2023 BioSpace.com. Liveyon Joh Kosolcharoen is s complete fraudster ripping off people and making them sick!! During the inspection of your firms Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, co-located at 22667 Old Canal Road, Yorba Linda, CA 92887, conducted between May 13, 2019 and May 23, 2019, the Food and Drug Administration (FDA) documented that Liveyon Labs processes human umbilical cord blood derived cellular products PURE and PURE PRO for allogeneic use (hereinafter, umbilical cord blood products or products). iv. Patients often didnt want the medicine or never had met the prescribing doctor. 4. the kind that should due you in are the very opportunity area to be better than ever before to overcome. Founded in 2016, Liveyon is pushing the boundaries of regenerative medicine with its innovative take on product research and development, manufacturing and distribution, and commitment to safety and transparency. 8. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry enhances the show's format, as they tackle groundbreaking topics and introduce experts in the field of regenerative medicine, including leading researchers and physicians. For example: a. FDA has identified Zika virus (ZIKV) as a relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2). Liveyon Pure Cast - The Stem Cell Market Bubble. They found that 20 patients in 8 states got bacterial infections after injections with the product. ', Media Contact:James Buzzacco[emailprotected] 844-548-3966, Cision Distribution 888-776-0942 Conformis, Inc., Bodycad Laboratories, Inc., and Bodycad USA Corp. have resolved their patent litigation. b. Liveyon Labs processed cord blood units from two different donors (b)(4). As this was apparent went FDA VISITED & flagged them for corrections which they ignored and also hid from LIVEYON. Failure to promptly do so may result in regulatory action without further notice. You have my opinion here but does not take a rocket scientist to see zero future doing the right thing LIVEYON. from 8 AM - 9 PM ET. For those who still want to try stem cells please do your research first.. John W Kosolcharoen - Orange County, California, United States After people starting getting sick, all the bad batch of vials of stem cells were destroyed and the finger-pointing began on who was to blame. Dont fund their greed. She loves writing about public health issues as well as the courage and resilience of patients facing illness. You folks should have better things to do. Billy MacMoron wake up!! Anyone with any sense of biz would fire that ROGUE contractor BUT stay in biz ! Im not aware of firms in this space having such approval at this time. 321(g)] and biological products as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. Specifically, the Liveyon Labs SOP LL-LAB-004v1, entitled PURE Product Production, failed to assure that the (b)(4) containers used during the manufacture of approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, did not alter the final product identity, strength, quality, and purity. Specifically, the products, manufactured from donated umbilical cord blood, are dependent on the metabolic activity of living cells for their primary function and are not for autologous use, allogeneic use in a first-degree or second-decree blood relative, or reproductive use.