Mother of Liveyon CEO Shares Heartfelt Stem Cell Success Story with Son We also acknowledge the other corrective actions you have taken in response to the observations. 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. The new epidemiological study in JAMA Network Open reports on a number of aspects of the large adverse event. Your complaint procedure LL-QA-015, entitled Product Complaint is not followed and is inadequate: a. 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. The number of colonies were not counted if greater than 1 and marked as 1+. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. He has signed a plea agreement and is awaiting a hearing. 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. Required fields are marked *. 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). 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. ', Media Contact:James Buzzacco844-548-3966[emailprotected], Cision Distribution 888-776-0942 Liveyon's Live 'Pure-Cast' Podcast Series Sheds Light on - BioSpace "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. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed. Kosolcharoen brought light to companies conducting fraudulent testing and doctoring numbers to enhance their brand while promoting a faulty productand called for manufactures to take more responsibility. 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. 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. Who Is Liveyon and What Are They Really Selling? reduced to how many come end of FDA 36 month roll out this Nov 2020??? For example: a. 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. 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. Information and records gathered at the time of and after the inspection, including product labeling and information on the Liveyon LLC website, https://liveyon.com, reflect that your products are intended to treat a variety of orthopedic conditions. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. . The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. Liveyon's Live 'Pure-Cast' Podcast Series Sheds Light on Miseducation 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. Its also not exosomes but conditioned medium containing fetal bovine serum that is going to kill someone. Copyright 2023 RRY Publications, LLC. 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. 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 race is on to track down what went wrong with several patients in Texas before more people get hurt. "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. 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. 355(i); 42 U.S.C. The new Liveyon Luma website makes it 100% clear now, if there was any longer any doubt, that they are all tied together because the website includes another video commercial harkening back for me to the Awakening ad. All rights reserved. ii. They found that 20 patients in 8 states got bacterial infections after injections with the product. Learn how your comment data is processed. Courtney strives to lead a healthy lifestyle that includes yoga and not microwaving plastic. 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. Death was a brilliant series about a rogue doctor that was unqualified at his job and made a lot of bad decisions that injured or killed many people. Whats your interest? 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. The most recent email I sent to Kosolcharoen some months back did not receive a reply. Surface monitoring is not conducted in the BSC for each fill. 3. 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. When typing in this field, a list of search results will appear and be automatically updated as you type. 264] and the regulations in 21 CFR Part 1271. Liveyon's Live 'Pure-Cast' Podcast Series Sheds Light on Miseducation Powered by Madgex Job Board Software. Liveyon Pure Cast on Vimeo The public? 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 is not an accurate statement. Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process. 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. b. Liveyon Labs processed cord blood units from two different donors (b)(4). In June the FDA warned Utah Cord Bank related to manufacturing issues. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. Her license to practice as a doctor of osteopathy was revoked. 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. 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. In order to market them in a compliant way you must have prior FDA approval. Such licenses are issued only after showing that the product is safe, pure, and potent. 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)]. 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 . 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. 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/). 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. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations. Also gives me a better appreciation of the cost multiplier between our research activities and a real clinical product. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. 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. An anonymous former employee confirms, the lack of care and effort towards ethical treatment of products and employees is astounding. 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). 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. 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.. 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 . 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. Seven from O.C. TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. FDA has granted 510(k) clearance to a trochanteric nailing system from X-Bolt Orthopedics. Laura Beil, host and reporter of Dr. Death, did an amazing job on a series that at times felt like a horror movie, but she just may have topped herself with her new six-part series, Bad Batch, that doesnt just call into question medical practices, but an entire largely unregulated industry - stem cells. But if something is wrong, we can't afford to lose our CEO, so I'll be first.". Complaint C-19-001 was received on April 26, 2019, forwarded to QA on the same day, and QA did not commence their investigation until May 1, 2019. ii. 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. 6. In fact, if you read their clinical support closely and do a little homework, you will understand the gimmick. During this time, (b)(4) vials of umbilical cord blood products were manufactured and subsequently distributed. 262(a)(3); 21 CFR Part 312]. DUH!!! 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. Department Finance . FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. During this time, (b)(4) lots were manufactured, totaling (b)(4) final product vials. Three of the five settling plates were positive for P. glucanolyticus. As this was apparent went FDA VISITED & flagged them for corrections which they ignored and also hid from LIVEYON. 2. 264]. While the two sat in John's office one afternoon, the good news arrived: After two years of hard work, compliance for Liveyon's Peer Series was complete and it was ready to launch. 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. b. You may opt-out by. Remember our old friends Liveyon? 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?". 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)]. The Orange County defendants were accused of crimes that involved billing Medicare for occupational therapy that was never provided, submitting false patient reports for state workers compensation and paying kickbacks for expensive prescriptions that were billed to TRICARE, the militarys insurance plan. In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). Its a topical cosmetic product. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? Liveyon's Live Pure-Cast Podcast Explores Hair Regeneration Success Several other firms seem to be actively supplying materials to customers. 'Is There A Stem Cell Bubble?' Liveyon CEO, Education - Insider For the full transcription of the show follow the link: (b)(4) vials were distributed without any environmental monitoring data demonstrating control of the immediate manufacturing environment. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. But Kosolcharoen offered a silver lining, saying further FDA regulation will clean up the industry and drive out fraudulent companies. Nor did you commit to providing any follow-up response(s) to address any corrective actions once implemented. "You know stem cells are real. Patients often didnt want the medicine or never had met the prescribing doctor. 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. 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. 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 . The researchers also had access to many unopened vials of the Liveyon product and examined those for contamination as well. Complaint closure is also performed by the CCO of Liveyon LLC/Liveyon Labs instead of Liveyon Labs QA. John W Kosolcharoen - Orange County, California, United States Postal Service. Failure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)]. 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. 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. 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. 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)]. 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. c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. 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. 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. 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. By the end of the episode, that man is revealed to be John Kosolcharoen, founder and CEO of Liveyon. For Lois, the next few years looked worrisome. The root cause and source of the contaminating organisms was not identified. Its all about informed consent but people arent getting it, she says. Contact Details. Liveyon PURE Debuts Clinical Trial Grade Stem Cell - BioSpace The CDC team also used next-gen sequencing to determine that all of the contamination likely originated from one source. 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. Dynamic Digital Radiography Better for Shoulder Injuries, Orthopedists Happiness Declined After Pandemic. 8. However all the negatives and many shortcoming with each and every one from this fiasco was OVERCOME by LIVEYON. ii. 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. It is unclear what that means, and whether it is a response to the adverse events related to Genetechs products, he said. as pain free as possible so each and every one can have their quality of life back long after normal limitations as they each regenerate inside out as GOD designed us all to do all along. 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. 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. 262(i)]. More Liveyon links to exosome Awakening film include - The Niche It was thought at the time that about a dozen patients who had been injected with the Liveyon product had been sickened. But if something is wrong, we can't afford to lose our CEO, so I'll be first.". 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). 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. 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. Her appeal was denied on December 24, 2010. Therefore, your products are not regulated solely under section 361 of the PHS Act [42 U.S.C. Although still an experimental industry, Dr. Behnam has seen unprecedented success treating hair . The route of administration for the umbilical cord blood products includes intra-articular injection. 4. I call it an unheard of A+++ endorsement as of last May 2019 . Karlton Watson 'Is There A Stem Cell Bubble?' Liveyon CEO, Education Director Discuss 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. Include any documentation necessary to show that correction has been achieved.