liveyon ceo john kosolcharoen

You have one central character, the industry itself, the science of it, and the regulations.. The researchers also had access to many unopened vials of the Liveyon product and examined those for contamination as well. All Rights Reserved. Thank you, JOHN K. / LIVEYON as I knight thee in becoming a very much need national and world MOST trusted UCB stem source .. the Phoenix from the flame rarity or rare kind . Liveyon sells the product to care providers who then inject it into patients for many different conditions. While bone marrow procedures were once known as a scientific breakthrough, Dr. Gaveck explains how new technology and discoveries have . 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. His arraignment was set for July 18. A Laguna Beach psychiatrist and six other Orange County residents have been charged with participating in Southern California health fraud schemes that bilked government insurance programs of more than $125 million, prosecutors said Wednesday. Its a topical cosmetic product. in Phoenix, pleaded guilty in 2008 to one felony count of unlawfully prescribing human growth hormone (HGH). "You know when you see companies popping up all over the place, when you see a stem cell clinic on every corner, when you see advertisers in papers and people just in it for the money. Specifically, your validation LL-VAL-010, entitled Validation of Biological Safety Cabinet Cleaning, v1, failed to challenge your procedures and cleaning agents to determine efficacy. The deficiencies include, but are not limited to, the following: 1. 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. We didnt receive a response. The umbilical cord products are not the subject of an approved biologics license application (BLA) nor is there an IND in effect. 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. b. Liveyon Labs processed cord blood units from two different donors (b)(4). The root cause and source of the contaminating organisms was not identified. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. 9. She grappled with the idea of how major surgery and years of physical therapy could still leave her reliant on canes and walkers. We recommend that you review FDA Guidance for Industry, Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (updated May 2018), available at https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm488582.pdf. Such monitoring is only conducted (b)(4) for surface sampling despite the manufacturing of (b)(4) lots per day. c. Step 3.4 states that investigations shall be initiated on the day information is received by QA. However, complaint investigations were not initiated on the day of receipt by QA. In order to market them in a compliant way you must have prior FDA approval. Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. At present I wasnt able to determine the current status of Liveyon as a company. Los Angeles' top dermatologist, Dr. Ben Behnam, joined Liveyon CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck on the latest episode of Liveyon Pure-Cast for an in-depth conversation on common misconceptions, scientific breakthroughs and popular issues surrounding hair regeneration. This terrifying tale of medical malpractice also shone a light on the problems with the medical system that could allow such an individual to bounce around from office to office and keep his medical license. The site is secure. Liveyon's continuing metamorphosis A screenshot from the Liveyon Luma exosomes website. Lynne Pirie is a graduate of the Michigan STATE college of osteopathic medicine, not to be confused with the Michigan state university college of human medicine (MD granting) nor the university of Michigan medical school. 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. The podcast provides a complimentary resource for clients of the company's new product line. This (b)(4) and (b)(4) are labeled For research use only.. 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. 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. The trail leads to a stem cell company with a charismatic CEO, and to an entire multibillion dollar industry where greed and desperation collide. 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. Department Finance . Treace Medical and Fusion Orthopedics have come to an agreement to resolve their legal dispute. 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 going forward will be thorough characterizations that describe the cell preparation and composition of products in greater detail. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. d. Liveyon Labs used a non-sterile (b)(4) and the associated non-sterile (b)(4) to manufacture approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, raising the potential for microbiological contamination. Additionally, during the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP), including deviations from section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210, 211, and 1271. You will see the number will be low. The exclusive video series streams live every Monday, Wednesday and Friday morning and features John Kosolcharoen, founder and chief executive officer of Liveyon and Dr. Alan Gaveck, director of education, Liveyon. Many successful companies have alot to overcome at certain points but its those very AMERICAN failure issues . Patients are offered a miracle cure, but instead they end up rushed to the hospital in critical condition. 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. Really Paul? Maybe, maybe not. The most recent email I sent to Kosolcharoen some months back did not receive a reply. Please include a copy of this letter with your initial submission to CBER. that have been on the market for a long time. the kind that should due you in are the very opportunity area to be better than ever before to overcome. Some of you might recall that Liveyon was tied to an odd sci-fi-like advertisement-short film called Awakening a few months back. 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). 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. 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. 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. Surface monitoring is not conducted in the BSC for each fill. 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. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. Three of the five settling plates were positive for P. glucanolyticus. 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)]. 5. She also played a major part in the rollout of Liveyon's Peer Series. 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. The key difference here from their past products is that this is apparently a cosmetic product rather than something intended for injection IV. 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 every Monday, Wednesday and Friday morning. Who is Liveyon. This site uses Akismet to reduce spam. Not exactly. and Buffalo Bone and Joint, PLLC have filed a $24.7 million lawsuit. Please check your inbox or spam folder now to confirm your subscription. Currently working as Chief Executive Officer at Liveyon LLC in California, United States. 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. 6. The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. All rights reserved. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. 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. We received Liveyon Labs written response, dated June 12, 2019, to the inspectional observations on the Form FDA 483, and we have reviewed its contents. Induced pluripotent stem cells or IPS cells. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. Its also notable that the FDA, even if not their CBER branch, has taken enforcement action on stem cell cosmetics in the past and could do so again. 262(i)]. ', Media Contact: 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. Contact plates are not an appropriate substitute for settling plates, as they are intended to recover organisms through direct contact with surfaces and not passive air sampling. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. YORBA LINDA, Calif., April 9, 2019 /PRNewswire/ -- Breaking from the traditional format of Liveyon's live 'Pure-Cast,' Liveyon founder and CEO sat down with his mother, Lois Christianson, in a heartfelt conversation on how stem cell treatment saved her life after a horrifying injury. 81 Million People: Hoda Kotb On The Massive Reach Of NBCs Today, How A Writers' Strike Could Kill Off Late Night Television, Peacock Busts Through 22 Million Subscriber Mark: Peak Losses In 2023 At $3 Billion, Recording Academy Pushes For Radio Royalties At Star-Packed Awards Dinner, Fox News Ratings At 8PM Drop 50% After Tucker Carlsons Firing, Comcast CEO Has To Answer For Jeff Shell's Exit And Peacock's More Than $700 Million Loss, Tucker Carlson Leaves A Bigger Hole At Fox Than Don Lemon At CNN, Fox News Wins Prime Time Ratings On First Night Without Tucker Carlson. Since manufacturing operations began in (b)(4), you (b)(4) processed (b)(4)% of your (b)(4) batches. 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. 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. Liveyon is a cord blood product marketer that distributed a batch of cells a couple of years back that led to many patients being hospitalized with infections. 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. 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. The way I see it is simple . 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. Not intended for diagnostic or therapeutic procedures.. 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. Sadly, very few, if any, actually read the small print and/or care enough to dive into the details. Imagine if dozens of more patients had been injected with those 34 vials. Failure to test donor specimens using appropriate FDA-licensed, approved or cleared donor screening tests, in accordance with the manufacturers instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases [21 CFR 1271.80(c)]. Theyvare selling topical creams. Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. She loves writing about public health issues as well as the courage and resilience of patients facing illness. Failure to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84(a)]. Im not aware of firms in this space having such approval at this time. Even so, Kosolcharoen (pictured with another Liveyon leader Alan Gaveck below in a web video) recently denied involvement in an . Irvine, CA 92612 While these fraudulent companies ravage the regenerative industry, Liveyon continues to provide an innovative take on product research, development, manufacturing and distribution, while prioritizing a commitment to safety and transparency. d. Liveyon Labs used a non-sterile (b)(4) and the associated non-sterile (b)(4) to manufacture approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, raising the potential for microbiological contamination. Therefore, your products are not regulated solely under section 361 of the PHS Act [42 U.S.C. The products are marketed and distributed, among other responsibilities, by Liveyon LLC. Your email address will not be published. Instead, patients received massage and acupuncture, which are not covered by Medicare. 57 companies ..???? 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. Also gives me a better appreciation of the cost multiplier between our research activities and a real clinical product. "The 'Liveyon Pure Cast' provides an important new tool for patients, physicians, and the general public to navigate this complex and ever-changing industry," said John Kosolcharoen, chief. Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell, Questions on National Academies in vitro gametogenesis (IVG) meeting sponsorship, Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells. All complaints are forwarded directly to the Chief Compliance Officer (CCO) of Liveyon LLC/Liveyon Labs for logging into the Liveyon LLC complaint system prior to routing to Liveyon Labs QA for logging into the Liveyon Labs complaint system, which initiates the investigation. Their leader John Kosolcharoen? We recommend that you review the violations listed above, consider the potential serious risks to patients your manufacturing violations present, and consult with third-party experts to implement comprehensive corrective action. Some had sepsis and ended up in the ICU. The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. Required fields are marked *. This practice, which you refer to as (b)(4) processing, is considered high risk and significantly increases the potential for cross-contamination and mislabeling. Orthopedic surgeon Paul Mason, M.D. 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. In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). 7. Phone +1*****44. The Liveyon home page says that the PREMIERMAXCB product is relatively safe and easy to use., An FDA regulatory attorney who looked at that language, Mark I. Schwartz of Hyman Phelps & McNamara, who was the Deputy Director in the Office of Compliance and Biologics Quality at FDAs Center for Biologics Evaluation and Research from 2012 to 2015, said that statement made me scratch my head.. 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. Are there other similar companies still operating in the U.S. even now? "We see fraudulent testing, where companies had a test done and then we found fraudulent documentation and tweaking of some of the numbers to make themselves look better," Kosolcharoen said. Karlton Watson 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. 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 . 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. Also, in the commercial video on the Liveyon Luma website they mention stem cell enhanced skin treatments, which potentially brings stem cell drug products into the mix too. "You know stem cells are real. [Suppling food, equip, tools, explosives, etc., etc{ to help the guy Work/ extend / live his/her dream as they choose. (b)(4) vials were distributed without any environmental monitoring data demonstrating control of the immediate manufacturing environment. GODSPEED. 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)]. The crucial question asked on Liveyon's 'Pure-Cast,' a video podcast focusing on uncovering the truth about the emerging field of regenerative medicine, was "Is there a stem cell bubble?". Such licenses are issued only after showing that the product is safe, pure, and potent. Ive been encouraging all my trainees, students, family, collaborators, and anyone else asking me about stem cells to take the time to listen to Bad Batch (https://wondery.com/shows/bad-batch/). They report: Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. Insiders Provide Real Solutions to the Tough Problems Plaguing the Industry. Specifically, the umbilical cord blood products fail to meet the 21 CFR 1271.10(a)(2) criterion that the HCT/Ps be intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturers objective intent.2 As noted above, the umbilical cord blood products are intended to treat a variety of orthopedic conditions. While regenerative medicine is still an experimental field, Liveyon has been a pioneer in the stem cell industry and manufacturer of thehighly acclaimedLiveyon Pureregenerative therapy umbilical cord stem cell product line. John Kosolcharoen, 44, of Santa Ana, charged with paying $100,000 in kickbacks for his work with Irvine Wellness Pharmacy, which received more than $11 million in 2015 from TRICARE. She eventually moved on to other jobs and raised a son.. 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. Strikingly, 19 out of these 20 patients required hospitalization. Lauras advice for people who are desperate for something to happen is to join a clinical trial where you are monitored by doctors with an expected outcome. Can clinic stem cell injections cause GVHD? Find John Kosolcharoen's accurate email address and contact/phone number in Adapt.io. 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, Liveyon Labs tested (b)(4) umbilical cord blood donors for ZIKV with a test that was not FDA licensed, approved, or cleared for HCT/P donor screening. Since Liveyon is just pitching an exosome cosmetic product does that mean they are OK FDA-wise? GENETECH WERE SECRETLY CUTTING CORNERS OVER TIME. The race is on to track down what went wrong with several patients in Texas before more people get hurt. And beyond all the science and the explanations, theres the story of the man behind it all. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry . 264] and the regulations in 21 CFR Part 1271. The new epidemiological study in JAMA Network Open reports on a number of aspects of the large adverse event. They found that 20 patients in 8 states got bacterial infections after injections with the product. The .gov means its official.Federal government websites often end in .gov or .mil. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. 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. Ive been writing about medicine for 25 years, Laura says, and the placebo effect is powerful. 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. Behind-the-Scenes Look at Events Surrounding FDA Recall of Genetech Products and Plans for Liveyon to Produce its Own Stem Cell Concentrate Derived from Umbilical Cord Blood . Liveyon LLC was incorporated on June 13, 2016. LIVEYON was a victim of this hurrendous negative as much as those innocent patients that got the bacteria were. ii. LIVEYON FIRED GENETECH; recalled the product and repaired that violent breech by never having to NOT KNOW AGAIN in completing their VERY own lab and making the UCB stem regenerative product like no other company to date.. offering both BIOLOGICS AND IND parameters do they can kickstart FDA approved clinical trials to prove scientifically the edge they envisioned and threaded through. You should take prompt action to correct these violations. 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. from 8 AM - 9 PM ET. An anonymous former employee confirms, the lack of care and effort towards ethical treatment of products and employees is astounding. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. You processed cord blood units from ineligible donors and destroyed the final product batches from donors who tested positive for relevant communicable diseases without conducting an investigation. 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. To me thats John K / LIVEYON . Those who commit fraud targeting health care funding get rich on the backs of American taxpayers who watch their premiums go up, Deirdre Fike, assistant director in charge of the FBIs Los Angeles field office, said in a statement. Ive had growing concern over the last 4-5 years about perinatal tissue and cell suppliers like Liveyon. The route of administration for the umbilical cord blood products includes intra-articular injection. Weekly reads: reprogramming hearing loss, heart disease, eye drops, sickle cell, Questions on National Academies in vitro gametogenesis (IVG) meeting sponsorship, Weekly reads: FDA nod on new cell therapy, gray hair, pong-playing cells. Does this mean theyve gotten to the pretty butterfly stage of corporate life? Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. Released immediately on bail, he was due to be sentenced on February 13, 2017, but has had several continuations, the most recent from January 28 of this year to September 30. Run from this company. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? 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.

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