U.S. Food and Drug Administration (FDA) inspectors found problems with records and quality controls for animal experiments at Neuralink by Elon Musk, less than a month after the startup announced it had approval to test their brain implants on humansaccording to an agency report reviewed by Reuters.
The inspectors identified Quality control failures at the company’s animal testing facility in California. A similar inspection at Neuralink’s Texas plant found no problems, according to agency documents.
These visits took place from June 12th to 22nd last year They represent the only inspections of Neuralink facilities recorded by the FDA. The inspectors’ reports were shared with Reuters by Redica Systems, a data analytics company that receives FDA compliance reports through open records requests.
“These issues demonstrate a lack of attention to detail,” said Jerry L. Chapman, senior quality expert at Redica Systems.
Laboratory problems identified by FDA inspectors These included missing calibration records for instruments such as a pH meter used in one of the studies. In another study, seven instruments, including a “vital signs monitor,” were known to be uncalibrated. Neuralink conducted experiments on hundreds of animals, including monkeys.
Additional problems included quality assurance officials’ failure to approve the final study report or document any deviations from approved protocols or standard operating procedures.
“This is certainly a sign that the company needs to be vigilant about certain practices,” Chapman said, adding that the company would need to use similar practices in its human trials.
Brain implant is being tested to help paralyzed patients have a spinal cord injury or amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, to communicate and move a computing device using your thoughts.
Reuters reported on this in December 2022 USDA investigators investigated possible animal welfare violations at Neuralink after internal employees complained that animal testing was being accelerated, resulting in unnecessary suffering and deaths.
An animal welfare advocacy group, the Physicians Committee for Responsible Medicine, filed a formal complaint with both the USDA and FDA about the alleged violations. In July, the agency said it had found no violations of its animal testing rules beyond a 2019 incident that Neuralink had previously reported.
The FDA has its own requirements for animal testing, Three regulatory experts told Reuters they are called “good laboratory practices” to demonstrate that all scientific data collected in the development of a drug or medical device is reliable.
Neuralink cited its animal testing data in its application to the FDA to test the implants in humans. Musk, the company’s billionaire founder, announced in May that his device had been approved for human trials said last month that the first patient had received an implant and recovered well.
Neuralink did not respond to questions about the FDA visit. The FDA has not provided information about the severity of the problems found during the inspection, according to the agency’s database. Although the problems identified are serious, do not appear to be significant enough to justify the worst rating the FDA inspection that would prompt action, experts said.
FDA spokeswoman Carly Pflaum said: Neuralink provided “sufficient information to support approval” of its request for a human trial. The agency routinely conducts these types of inspections, Pflaum said, after approval for human trials and before marketing approval to ensure “the integrity and reliability of the data” and compliance with other FDA regulations.
“The FDA will continue to monitor the safety of those participating in the Neuralink implant study through required regular reporting,” Pflaum said.
Ryan Merkley, head of research advocacy at the animal welfare group PCRM, said the FDA should have reviewed Neuralink before approving the human trialgiven concerns his organization had raised months earlier.
Victor Krauthamer, former longtime FDA official, said the authority was responsible for conducting the inspection before allowing the company to proceed with its clinical trial, and has done so in other cases as well.
“It would have made sense if the FDA had done the inspection before approving human trials,” said Krauthamer, who once reviewed brain implant applications for human trials at the agency. “These are violations of basic requirements and there is no reason to worry that they will be repeated in human experiments.”
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