liveyon ceo john kosolcharoen

Complaint closure is also performed by the CCO of Liveyon LLC/Liveyon Labs instead of Liveyon Labs QA. 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)]. For example: a. the doctors / patients using LIVEYON did not abandon their use and even the FDA recent spring of 2019inspections witnessed LIVEYON excelling and delivering MORE than ever actually expected &/or required. Liveyon's continuing metamorphosis A screenshot from the Liveyon Luma exosomes website. A woman named Lynne Pirie of Phoenix, Arizona, has identified herself online, in LinkedIn and in postings defending the company on blogs, as the Territory Manager Southwest USA for Liveyon since August 2018, and says she has a Doctor of Osteopathy degree from the University of Michigan. He pleaded guilty on August 23, 2016 to one federal felony after it was alleged that he had headed a TRICARE kickback and fake prescriptions scheme from late 2014 through his arrest date. 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. They started selling another in-house produced product. ii. In other cases, marketers provided pharmacies with illegally obtained information on beneficiaries and then prescriptions were mailed to them each month. "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. 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. Since manufacturing operations began in (b)(4), you (b)(4) processed (b)(4)% of your (b)(4) batches. 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]. The route of administration for the umbilical cord blood products includes intra-articular injection. 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. James Buzzacco When typing in this field, a list of search results will appear and be automatically updated as you type. Listen to Bad Batch. It's remarkable.". 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. because they were burned before in this unfortunate incidence of fall of 2018 brought but they did not die. 355(i); 42 U.S.C. 3. Therefore, your products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. Neither this letter nor the observations noted on the Form FDA 483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist at your facility. 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. Ive had growing concern over the last 4-5 years about perinatal tissue and cell suppliers like Liveyon. This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. 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. Liveyon Founder and CEO John Kosolcharoen and Director of Education Dr. Alan Gaveck discussed the differences on 'Pure-Cast' with stem cell experts, Dr. Margaret Coutts, Chief Scientific Officer for Liveyon and Dr. Rafael Gonzales, a prominent industry expert.. They are in it for a quick buck. This is the American come back stronger story that you are proud to back and renew your trust accordingly . 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. 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. more and more 24/7. Can clinic stem cell injections cause GVHD? if I hire a contractor to do specific work as agreed and he / she goes rogue on our agreements I am floored and discontinue / fire that contractor. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. Failure to screen a donor of cells or tissues by reviewing the donors relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. 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)]. You have one central character, the industry itself, the science of it, and the regulations.. Since operations began in January 2019, Liveyon Labs has processed cord blood units from(b)(4) donors supplied by (b)(4), located in (b)(4), and cord blood units from (b)(4) donors supplied by (b)(4), located in (b)(4). Currently working as Chief Executive Officer at Liveyon LLC in California, United States. 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. The site is secure. His arraignment was set for July 18. I call it an unheard of A+++ endorsement as of last May 2019 . iv. Clearly LIVEYON was running a very dangerous, illegal and unethical snake oil shop. 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. The CDC team also used next-gen sequencing to determine that all of the contamination likely originated from one source. When typing in this field, a list of search results will appear and be automatically updated as you type. Get Phone Number. Note that the new Liveyon Luma video may be not safe for work entirely so be a little careful. 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. Therefore, your products are not regulated solely under section 361 of the PHS Act [42 U.S.C. In a second round of questions, we asked Liveyon through an outside spokesman whether the two individuals in company management and the two named in these legal actions were the same people. Insiders Provide Real Solutions to the Tough Problems Plaguing the Industry. Their leader John Kosolcharoen? What about the FDA or other agencies proactively stopping such marketing of risky and unproven cell products? All Rights Reserved. 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. 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. Treace Medical and Fusion Orthopedics have come to an agreement to resolve their legal dispute. 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. "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. There was a recall, an FDA warning letter, lawsuits, and a voluntary suspension of sales by the company. They found that 20 patients in 8 states got bacterial infections after injections with the product. Liveyon CEO, John Kosolcharoen, was arrested on healthcare fraud in 2016. 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. For example: a. Liveyon Labs failed to adequately validate the aseptic process used to manufacture your PURE and PURE PRO products since operations began in January 2019. 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. "As the CEO and founder of Liveyon and Liveyon labs, I said 'of course I want to be the first person that tries the new product, I'll take the first flagship injection,'" Kosolcharoen said at the time. The researchers also had access to many unopened vials of the Liveyon product and examined those for contamination as well. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? 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. Randy Jett, 70, of Lake Forest, charged with offering to pay a doctor for writing prescriptions. THEY did right by the patients and doctors in every way possible the moment light dawned as they knew they were conned / shortchanged (label it as you please) as the six figure payments paid for that exclusive proprietary specific formulation of was NOT as LIVEYON agreed or contractualized .. it was GENETECH who went rogue. After successfully injecting himself with stem cells and later his mother, he was convinced that he had found the answer that people were looking for, along with a way to make a lot of money. If you are this sloppy about this detail I dont think your article holds much weight. The bulk of the show is about John Kosolcharoen, the charismatic CEO of Liveyon, an ambitious stem cell company that raced ahead of existing research to provide cure-alls to patients who. Its also not exosomes but conditioned medium containing fetal bovine serum that is going to kill someone. 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. 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. For further information about IND requirements for biological products, contact the Center for Biologics Evaluation and Research (CBER), Division of Regulatory Project Management, Office of Tissues and Advanced Therapies, at (240) 402-8190, or OTATRPMS@fda.hhs.gov. b. Liveyon Labs processed cord blood units from two different donors (b)(4). This practice, which you refer to as (b)(4) processing, is considered high risk and significantly increases the potential for cross-contamination and mislabeling. This site uses Akismet to reduce spam. LIVEYON allows science to speak the results for itself. The number of colonies were not counted if greater than 1 and marked as 1+. Additionally, 1+ was inaccurately recorded as 1 CFU in the Positive Sterility and EM Log. 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?) At a Wondery listening party Q and A for Bad Batch, Laura told me that to tell a big story like this narratively You have to pick out the details that matter most, but leave in enough to tell the story. 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. You have my opinion here but does not take a rocket scientist to see zero future doing the right thing 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. 7. 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)]. 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 Failure to promptly do so may result in regulatory action without further notice. Some had sepsis and ended up in the ICU. Even so, Kosolcharoen (pictured with another Liveyon leader Alan Gaveck below in a web video) recently denied involvement in an . 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. 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. "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. As stated above, because your products do not meet all the criteria in 21 CFR 1271.10(a), and Liveyon Labs does not qualify for any exception in 21 CFR 1271.15, the products are regulated as drugs as defined in section 201(g) of the FD&C Act [21 U.S.C. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an IND in effect as specified by FDA regulations [21 U.S.C. Get Email Address. If you have any questions, please contact Mr. Cline at (949) 608-4433 or via e-mail. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. Not intended for diagnostic or therapeutic procedures.. b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. 6. In a letter to clients, Liveyon LLC Chief Executive Officer John Kosolcharoen said the company has halted distribution of its products, Pure and Pure Pro, to "focus its efforts" on getting. 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. Her appeal was denied on December 24, 2010. 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. 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. 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. 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. The race is on to track down what went wrong with several patients in Texas before more people get hurt. "I think all of those things will catch up to the industry and the FDA is going to have to come in and put some type of heavy regulation it.". She was queasy when she watched surgery for the first time (a knee replacement) especially when a drop of blood splattered in her notebook! 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 . 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. 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. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. iii. Two Chattanooga orthopedic surgeons and a former chief information officer have filed a whistleblower lawsuit. The key difference here from their past products is that this is apparently a cosmetic product rather than something intended for injection IV. 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. Please check your inbox or spam folder now to confirm your subscription. Founded in 2016, 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. 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. The number was actually much higher it seems, based on a new report. The new epidemiological study in JAMA Network Open reports on a number of aspects of the large adverse event. iv. [Suppling food, equip, tools, explosives, etc., etc{ to help the guy Work/ extend / live his/her dream as they choose. By the nature of their routes of administration, your products purport to be sterile and are expected to be sterile. Concerningly, one of the issues noted by the agency was You failed to validate your microbiological testing.. 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. 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. 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. Dr. Gaveck brings 13 years of experience in both clinical and surgical medical treatments and the two hosts' intellectual chemistry .
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