{"id":2189438,"date":"2024-02-29T16:20:02","date_gmt":"2024-02-29T21:20:02","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-musks-neuralink-brain-implant-company-cited-by-fda-over-animal-lab-issues\/"},"modified":"2024-02-29T16:24:45","modified_gmt":"2024-02-29T21:24:45","slug":"exclusive-musks-neuralink-brain-implant-company-cited-by-fda-over-animal-lab-issues","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-musks-neuralink-brain-implant-company-cited-by-fda-over-animal-lab-issues\/","title":{"rendered":"FDA cites Neuralink over animal lab issues"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fexclusive-musks-neuralink-brain-implant-company-cited-by-fda-over-animal-lab-issues%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2189438&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p><!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\"><br \/>\n<?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><?xml encoding=\"utf-8\" ?><html><body><\/p>\n<div class=\"entry-content\">\n<p><strong>Breaking News: FDA Inspectors Find \u2064Quality Control Issues \u2064at Neuralink<\/strong><\/p>\n<figure class=\"wp-block-image size-full\"><figcaption class=\"wp-element-caption\">Neuralink logo and Elon\u200c Musk photo are seen in this illustration taken, December 19, 2022. REUTERS\/Dado \u2062Ruvic\/Illustration\/File Photo<\/figcaption><\/figure>\n<p>In a\u200b recent report \u200dreviewed by Reuters, it \u200chas been revealed that U.S.\u2064 Food and \u2063Drug Administration (FDA) \u200binspectors have discovered \u200bproblems with record keeping and quality controls for\u2063 animal experiments at Elon Musk&#8217;s\u200c Neuralink. This comes less\u200b than a month after the startup\u200b announced it was cleared to \u200dtest its brain implants \u2062in humans.<\/p>\n<div id=\"div-gpt-ad-1663871513696-art-3\" style=\"min-width: 320px; min-height: 50px; text-align: center;\">  \t<script>  \t\tgoogletag.cmd.push(function() { googletag.display('div-gpt-ad-1663871513696-art-3'); });  \t<\/script>  <\/div>\n<div class=\"ad-slot__ad-label\">Advertisement<\/div>\n<\/p>\n<p>The FDA inspectors found quality control lapses at Neuralink&#8217;s California animal\u2062 research facility. \u2063However, no problems were identified during a similar inspection at the company&#8217;s Texas facility.<\/p>\n<p>These inspections, which\u200b took place\u200d from \u200cJune 12-22 last year, are the only recorded\u2063 visits by the FDA \u200bto Neuralink facilities. The inspector reports were obtained by Redica Systems,\u200c a \u2062data analytics\u200b company specializing\u200b in FDA compliance reports.<\/p>\n<p>&#8220;These issues indicate a lack of attention to detail,&#8221; commented Jerry L. Chapman, a senior\u2062 quality\u200d expert with Redica Systems.<\/p>\n<p>The FDA inspectors discovered several laboratory problems, including\u200d missing calibration records for instruments used in the studies. They also found that \u2064quality assurance officials had not\u200b signed off \u2064on final study reports or documented any\u200c deviations\u2064 from\u200c approved protocols or <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fatal-2021-jet-crash-was-likely-caused-by-parking-brake-left-on-during-takeoff-ntsb-says\/\" title=\"NTSB: Jet crash likely due to parking brake left on during takeoff\">standard operating \u200bprocedures<\/a>.<\/p>\n<p>Neuralink has conducted \u2062experiments\u2063 on hundreds of\u2064 animals, including monkeys, \u2064as \u200dpart of its research \u200bon\u200c brain implants to help\u2063 paralyzed patients communicate using\u2064 their thoughts.<\/p>\n<p>Earlier reports had already raised concerns \u200dabout Neuralink&#8217;s \u200danimal\u200c testing practices, with \u2063allegations of rushed experiments causing unnecessary suffering and deaths. The FDA has not yet issued \u2063a \u2062designation indicating the severity of the\u200b problems found in the inspection.<\/p>\n<h2 class=\"wp-block-heading\">FDA Inspection \u2063Raises Concerns<\/h2>\n<p>The FDA\u2063 has \u200bits own requirements for animal \u2064research, known as \u200bGood Laboratory\u200c Practice, to ensure\u200d the reliability of scientific data collected during the development of \u2063medical devices. Neuralink had cited its animal research data in\u200c its FDA request to \u2062test the\u200b implants in humans.<\/p>\n<p>Neuralink has not\u200b responded\u200b to\u2064 questions regarding the FDA \u200cvisit.\u200d However, an FDA spokesperson stated that the agency had \u200bconducted the inspection after \u2062approving the human trial application\u200c and would continue \u2064to \u2062monitor the \u200bsafety \u200cof\u200b participants \u200bin the\u200b study.<\/p>\n<p>Animal welfare groups and former FDA officials have criticized the\u200c agency for not inspecting Neuralink before \u200bapproving the human trial,\u2063 given the concerns raised about \u200bthe \u200dcompany&#8217;s practices.<\/p>\n<p><sup>Reporting by Marisa Taylor; Editing by Michele\u200c Gershberg and \u2064Bill Berkrot<\/sup><\/p>\n<\/p>\n<div id=\"rc-widget-10bad2\" data-rc-widget data-widget-host=\"habitat\" data-endpoint=\"\/\/trends.revcontent.com\" data-widget-id=\"278641\"><\/div>\n<p class=\"dpsp-share-text\" style=\"margin-bottom:10px\"> \t\t \t\tShare this post!\t<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>with\u200b Carolyn Phippen<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>with \u200cBill Wells<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>with Seamus Bruner<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>with Hogan Gidley<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>UnitedHealth Group\u200c faces a major data breach as hackers claim to have stolen millions of sensitive records.<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>Legal battle ensues\u2064 as \u200cX challenges the Center\u200c for Countering \u2064Digital Hate\u2019s criticism of hate\u200c speech.<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>Bitcoin surges towards a record high fueled by ETF approvals and investor\u200c excitement, marking its largest \u2063monthly gain in over \u2062three years.<\/p>\n<\/p><\/div>\n<div class=\"entry-content\">\n<p>A California state \u2063judge tentatively rules in favor of \u200b6,000 Black factory \u200bworkers for alleged race discrimination\u200d and harassment.<\/p>\n<\/p><\/div>\n<p> rnrn  <\/p>\n<h2> What specific <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/red-flags-surrounded-the-missing-titanic-sub-years-before-disappearance\/\" title=\"Titanic Sub's Disappearance Preceded by Red Flags\">quality control issues<\/a> were identified by the FDA inspectors during their inspection of\u200b Neuralink&#8217;s California facility?<\/h2>\n<p><span>  Omplied with these requirements for human testing, but the recent FDA inspection raises concerns about the\u2062 company&#8217;s adherence to these guidelines in their animal experiments.<\/p>\n<p>Good Laboratory Practice (GLP) regulations\u200d were established by\u200d the FDA to\u2064 ensure the quality and integrity of data generated from nonclinical laboratory studies.\u2064 These regulations pertain to the organizational processes and conditions under which the studies are planned, \u200dperformed, monitored, recorded,\u200c and reported. GLP compliance is crucial in order to ensure\u2063 the safety and efficacy of medical devices and other products before they are\u200c tested on humans.<\/p>\n<p>During the inspection of Neuralink&#8217;s California \u200cfacility, FDA \u200binspectors found \u200dseveral lapses in quality control. Missing calibration records for instruments used in the studies and the absence of signed-off final study reports indicate a lack of attention to detail and raise concerns about the \u2063reliability of the data generated from these experiments. Additionally, the failure to document\u2062 deviations from approved protocols or standard operating procedures further undermines the\u2064 integrity of the research conducted at Neuralink.<\/p>\n<p>It is worth noting that\u200b no \u200dsimilar issues were identified in the inspection of Neuralink&#8217;s\u2063 Texas facility. This discrepancy suggests that the quality control issues \u200bmay be specific\u200c to certain locations or practices within the organization.<\/p>\n<p>Neuralink has conducted experiments on hundreds of animals,\u200b including monkeys, as part\u2064 of its research on brain implants for paralyzed patients. These experiments aim to develop a communication system that allows patients to communicate using their thoughts. However, earlier reports had already raised concerns about Neuralink&#8217;s animal\u200c testing practices, alleging rushed experiments that <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/dr-oz-running-for-u-s-senate-as-a-republican-has-a-history-of-donating-to-democrats\/\" title=\"Dr. Oz, Running For U.S. Senate As A Republican, Has A History Of Donating To Democrats\">caused unnecessary suffering<\/a> and deaths.<\/p>\n<p>The FDA \u2063inspection has \u200braised further concerns about the welfare of the animals involved in\u200d Neuralink&#8217;s research. Ethical treatment of animals is of utmost importance in scientific\u200d research, and any failure to \u2063comply with guidelines that protect their well-being demands immediate attention and corrective measures.<\/p>\n<p>The severity of the issues found in \u2064the FDA inspection has not yet been officially \u2062designated. It is crucial \u2062for Neuralink to\u200c take these findings seriously and address the identified lapses in \u200dquality control promptly. By\u200b doing so, the company can ensure \u200cthe reliability \u2063of its preclinical data and demonstrate the highest standards of ethical conduct\u2062 in animal\u2063 research.<\/p>\n<p>This incident also highlights the importance of regulatory oversight in \u2063scientific research. FDA inspections play a vital\u2062 role in ensuring compliance with guidelines and regulations, and companies like \u2062Redica Systems, specializing in FDA compliance reports, contribute to transparency and accountability in the industry.<\/p>\n<p>In light of the FDA inspection findings, it is essential for Neuralink to reevaluate and strengthen its <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/cooking-spray-burn-victim-awarded-7-1-million-in-damages-after-can-exploded-into-a-fireball\/\" title=\"Cooking spray burn victim receives .1 million in damages due to fiery can explosion.\">quality control processes<\/a>, particularly in\u2064 its animal research facilities. The company\u200d must prioritize the well-being of the animals involved and work towards gaining the trust of regulatory authorities \u200dand the public. Only through \u2064rigorous adherence to \u2062ethical and scientific standards can \u2062Neuralink regain confidence in its\u2062 research practices and advance towards its goal of revolutionizing brain-machine interfaces.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>February 29, 2024 \u2013 9:20 AM PST: FDA inspectors discover record-keeping and quality control issues for animal experiments at Elon Musk&#8217;s Neuralink, just weeks after the Neuralink logo and Musk&#8217;s photo were seen in an illustration taken on December 19, 2022. (55 words)<\/p>\n","protected":false},"author":1911,"featured_media":2189439,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/c3.oann.com\/wp-content\/uploads\/2024\/01\/LTQROFR4B5P5DMYQ4DSIHKEKH4.webp","fifu_image_alt":"","footnotes":""},"categories":[542],"tags":[],"class_list":["post-2189438","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-oann"],"fifu_image_url":"https:\/\/c3.oann.com\/wp-content\/uploads\/2024\/01\/LTQROFR4B5P5DMYQ4DSIHKEKH4.webp","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2189438","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1911"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2189438"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2189438\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2189439"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2189438"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2189438"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2189438"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}