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. 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. Because the umbilical cord blood products are not intended to perform the same basic function or functions of umbilical cord blood in the recipient as in the donor, such as forming and replenishing the lymphohematopoietic system, using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c). 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)]. And beyond all the science and the explanations, theres the story of the man behind it all. 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)]. 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 deficiencies include, but are not limited to, the following: 1. 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. (b)(4) used in the manufacture of your products. In a rare and heartfelt interview, the mother of John Kosolcharoen, founder and CEO of the acclaimed stem cell manufacturing company Liveyon, reveals a vulnerable side to stem cell therapy.. But Kosolcharoen offered a silver lining, saying further FDA regulation will clean up the industry and drive out fraudulent companies. This is the Wild West west of regenerative medicine but this did not get LIVEYON to give up . 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]. 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. 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). Note that the new Liveyon Luma video may be not safe for work entirely so be a little careful. (b)(4) used in association with the (b)(4) to remove the red blood cells from the umbilical cord blood. This is not an accurate statement. The key difference here from their past products is that this is apparently a cosmetic product rather than something intended for injection IV. 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. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. 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. Courtney strives to lead a healthy lifestyle that includes yoga and not microwaving plastic. 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 . Geez. As this was apparent went FDA VISITED & flagged them for corrections which they ignored and also hid from LIVEYON. 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. She loves writing about public health issues as well as the courage and resilience of patients facing illness. d. Liveyon Labs failed to accurately record the number of colony-forming units (CFUs) for each positive settling plate: i. John blamed the doctors who purchased the stem cells from him for improper handling of the vials even though the FDA didnt share his conclusions. 262(i)]. 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. 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.. 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. Postal Service. 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. 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. 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)]. FDA acknowledges Liveyon Labs decision to cease the receipt of umbilical cord blood from (b)(4), located in (b)(4). LIVEYON allows science to speak the results for itself. Unfortunately, theres evidence that 90 percent of drugs that go into clinical trials dont work and the general public is often misled by slick advertising that often uses exaggerated or misleading claims. It's remarkable.". The race is on to track down what went wrong with several patients in Texas before more people get hurt. But Kosolcharoen, who launched Liveyon in 2016, told his mom to fly out to California for stem cell treatment instead. Also, a man named John W. Kosolcharoen, who at the time lived in Rancho Margarita, 22.3 miles down the I-5 interstate from Yorba Linda, agreed to be banned from selling securities in October 2014 after the Securities and Exchange Commission accused him of being the lead salesman for a massive securities Ponzi scheme in Southern California. 262(i)]. 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. Liveyon LLC was incorporated on June 13, 2016. She grappled with the idea of how major surgery and years of physical therapy could still leave her reliant on canes and walkers. b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. She also played a major part in the rollout of Liveyon's Peer Series. By the end of the episode, that man is revealed to be John Kosolcharoen, founder and CEO of Liveyon. 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. Ive had growing concern over the last 4-5 years about perinatal tissue and cell suppliers like Liveyon. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps. There are no quick fixes! Additionally, 1+ was inaccurately recorded as 1 CFU in the Positive Sterility and EM Log. 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. The scary part is that theres still a lot we dont know about stem cell treatments. 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. Also gives me a better appreciation of the cost multiplier between our research activities and a real clinical product. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Concerningly, one of the issues noted by the agency was You failed to validate your microbiological testing.. 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. b. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. At present I wasnt able to determine the current status of Liveyon as a company. 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. Doctors allegedly were paid kickbacks for prescribing medications with reimbursements of up to $15,000. Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. Sadly, very few, if any, actually read the small print and/or care enough to dive into the details. 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. You have one central character, the industry itself, the science of it, and the regulations.. It's remarkable.". 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. b. Liveyon Labs processed cord blood units from two different donors (b)(4). 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?". In order to market them in a compliant way you must have prior FDA approval. During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis. 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. Find John Kosolcharoen's accurate email address and contact/phone number in Adapt.io. Some of you might recall that Liveyon was tied to an odd sci-fi-like advertisement-short film called Awakening a few months back. Based on this information, we have determined that your actions have violated the FD&C Act and the PHS Act. A doctor injected stem cells below her kneecapand within 15 minutes, the severe pain was gone. Its a topical cosmetic product. 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. 262(a)]. Seven from O.C. The number of colonies were not counted if greater than 1 and marked as 1+. Many successful companies have alot to overcome at certain points but its those very AMERICAN failure issues . Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. In addition, they were the subject of the podcast Bad Batch that shone a bright light on the company. ', Media Contact:James Buzzacco844-548-3966[emailprotected], Cision Distribution 888-776-0942 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. 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. 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. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps. 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. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. Your response should be sent to the following address: Daniel W. Cline, Compliance Officer, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612 or emailed to Daniel.Cline@fda.hhs.gov. 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. "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. You should take prompt action to correct these violations. Your email address will not be published. But, just as John was there for his mother when she suffered her knee injury, she was there for him, too. 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. Liveyon Pure Cast - The Stem Cell Market Bubble. ', Media Contact:James Buzzacco[emailprotected] 844-548-3966, Cision Distribution 888-776-0942 Your firm did not implement corrective or preventive actions. Doing translation right is hard! Its leader John Kosolcharoen is still listed as CEO of the company on LinkedIn. That website and video was made in 2017. What about the FDA or other agencies proactively stopping such marketing of risky and unproven cell products? c. The gowning procedure LL-QA-014, entitled Gowning Qualification Program, has not been implemented. In other cases, marketers provided pharmacies with illegally obtained information on beneficiaries and then prescriptions were mailed to them each month. 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. Are autoimmune or stem cell transplant patients at higher risk from COVID-19? 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. from 8 AM - 9 PM ET. This is obviously a smear campaign. b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. While bone marrow procedures were once known as a scientific breakthrough, Dr. Gaveck explains how new technology and discoveries have . Contact Details. 355(i); 42 U.S.C. 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. 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. I call it an unheard of A+++ endorsement as of last May 2019 . 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 joe tapper related to jake tapper,
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