Who Is Liveyon and What Are They Really Selling?

The way I see it is simple …. 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. Short cuts or any contractor doing their own thing unbeknownst to LIVEYON was not what they were exclusively paying for.
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 …. month to month. GENETECH WERE SECRETLY CUTTING CORNERS OVER TIME.

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. As this was apparent went FDA VISITED & flagged them for corrections which they ignored and also hid from LIVEYON. Genentech went rogue and since LIVEYON was helping the docs with all aspects of biz the other folk started to spin 99% negatives. Anyone with any sense of biz would fire that ROGUE contractor BUT stay in biz !
This is the Wild West west of regenerative medicine but this did not get LIVEYON to give up …. but made them FAR BETTER EQUIPPED FOR REGENERATIVE FUTURE because they did the right thing when this all came to light. LIVEYON was a victim of this hurrendous negative as much as those innocent patients that got the bacteria were. There was safety checks but if unperformed or not corrected (even for that May FDA visit there that resulted in corrective actions) why was it hidden from LIVEYON or FDA corrections complied to ignored before patients mishaps starting later in the fall?
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 LIVEYON’s own lab was complete.
DUH!!! You have my opinion here but does not take a rocket scientist to see zero future doing the right thing LIVEYON. However all the negatives and
many shortcoming with each and every one from this fiasco was OVERCOME by LIVEYON. Most internet wanted LIVEYON’s rising favored star to crash. Like Trump never expected to win his presidential election …. LIVEYON had a higher purpose in pulling through all this muck and mur this past 2019 because now FDA is using LIVEYON as the industry’s GOLD STANDARD WITH THEIR OWN PURE PRODUCT MFG. 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.

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. Many successful companies have alot to overcome at certain points but it’s those very AMERICAN failure issues …. the kind that should due you in are the very opportunity area to be better than ever before to overcome.

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. LIVEYON
allows science to speak the results for itself. It is the only company that has its FDA registered lab and since last winter of 2019 produces and mfg it own products A yo Z cause it learned the hard way that at the end of the day; rogue contractors or third party mfg trust cannot be trusted 24/7 as you gotta be the only cook in your own kitchen….. (lab). This is the American come back stronger story that you are proud to back and renew your trust accordingly …. the doctors / patients using LIVEYON did not abandon their use and even the FDA recent spring of 2019’inspections witnessed LIVEYON excelling and delivering MORE than ever actually expected &/or required. I call it an unheard of A+++
endorsement as of last May 2019 …. because they were burned before in this unfortunate incidence of fall of 2018 brought but they did not die. LIVING BEYOND is its name LIVEYON so can I please share to some great folk of doctor and patient alike to not fear from all the negative nay sayers on the internet meant to stir the pot to redirect the public to not trust LIVEYON when like OVERSTOCK owner and IPHONE founder who blazed their own high road within the industry’s industry …… few follow but the voice of science and many future clinical trials will vindicate the integrity and real character of JOHN K. as he helps change the paradigm of medical history through LIVEYON products for you need thee absolute consistency of each & every vial to
to get reproducible favorable results so my bet is on this company to change or extend my life anyday.
Remember this 2017 to date has been part of the very WILD WILD WEST of stem industry in AMERICA initially.
57 companies …..???? reduced to how many come end of FDA 36 month roll out this Nov 2020??? You will see the number will be low. If you recall all those gold rushers in the Wild Wild West of our CA gold rush …. very few actually found gold but the person who sold the tools to
implement & extend each gold rushers intended plan were the actual winners financially overall. [Suppling food, equip, tools, explosives, etc., etc{ to help the guy Work/ extend / live his/her dream as they choose. To me that’s John K / LIVEYON …. just faithfully (after this better reformulation and transformation) better extend patients lives doing what they wanna do …. 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. 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 …. more and more 24/7.
GODSPEED.

In response to this comment.

{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 …. month to month.}

This is not an accurate statement. 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.

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. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. The deficiencies include, but are not limited to, the following:

1. Failure to screen a donor of cells or tissues by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. 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). 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). 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 “DT-001 Form 1 Recovery Site Assessment” received from cord blood supplier (b)(4) did not adequately assess a donor’s residence in, or travel to, areas identified by the Centers for Disease Control and Prevention with active ZIKV transmission. 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.

b. 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).

2. Failure to test donor specimens using appropriate FDA-licensed, approved or cleared donor screening tests, in accordance with the manufacturer’s instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases [21 CFR 1271.80(c)]. 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. Liveyon Labs relied on such tests, which is not appropriate to prevent the introduction, transmission, or spread of ZIKV through HCT/Ps.

3. 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. Liveyon Labs failed to adequately validate the aseptic process used to manufacture your PURE® and PURE PRO® products since operations began in January 2019. By the nature of their routes of administration, your products purport to be sterile and are expected to be sterile. The media fill batch sizes used for your validation study LL-VAL-004, entitled “Validation of Aseptic Processing of the PURE® Product”, did not represent the maximum commercial batch size. The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials.

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. Since manufacturing operations began in (b)(4), you (b)(4) processed (b)(4)% of your (b)(4) batches. 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.

c. The gowning procedure LL-QA-014, entitled “Gowning Qualification Program,” has not been implemented. Appropriate gowning reduces the potential for the manufacturing personnel to inadvertently contaminate the product during the aseptic manufacturing process.

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. This (b)(4) and (b)(4) are labeled “For research use only.”

4. 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]. For example:

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. 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”.

ii. 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. During this time period, donors tested positive for ZIKV, Hepatitis B, and syphilis.

iii. Despite (b)(4) processing (b)(4)% of your cord blood units, your investigations failed to extend to the (b)(4) processed batches. 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.

iv. Your firm did not implement corrective or preventive actions.

b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. Three of the five settling plates were positive for P. glucanolyticus. The root cause and source of the contaminating organisms was not identified. No corrective actions were implemented, and four impacted in-process batches were subsequently distributed. In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation.

Clearly LIVEYON was running a very dangerous, illegal and unethical “snake oil” shop.