The FDA cited Elon Musk’s brain implant company for quality control failures

US Food and Drug Administration inspectors (FDA) found problems with records and quality controls for animal experiments in Neuralink of Elon Muskless than a month after the startup said it had permission to test its brain implants on humans, according to an agency report reviewed by the agency. Reuters.

Inspectors found quality control failures at an animal research company in California. A similar inspection at Neuralink’s Texas facility found no problems, according to agency records.

Those visits took place last year from June 12 to 22 and represent the only inspections recorded by the FDA at Neuralink facilities. The inspectors’ reports were shared with Reuters according to Redica Systemsa data analytics company that obtains FDA compliance reports through open records requests.

“These problems show a lack of attention to detail,” said Jerry L. Chapman, chief quality officer at Redica Systems.

Including lab problems found by FDA inspectors missing calibration records for instruments such as a pH meter used in one of the studies.

In another study, seven machines, including a “vital signs monitor”, had no record of having been calibrated. Neuralink has conducted experiments on hundreds of animals, incl monkey.

Other problems included quality assurance officials not approving the final study report or documenting any deviations from approved protocols or standard operating procedures.

“This is certainly an indication that the company needs to be cautious about certain practices,” Chapman said, adding that the company will have to follow similar procedures for its human trials.

A brain implant is being tested to help patients paralyzed by spinal cord injury or amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, communicate using thoughts to move a computing device.

Reuters in December 2022, researchers from the Department of Agriculture (USDA) reported that they were investigation into possible animal welfare violations at Neuralink following internal employee complaints that their testing was rushed, causing unnecessary suffering and death.

In July, the USDA said it had found no violations of its animal research rules beyond the 2019 incident that Neuralink had already reported.

The FDA has its own requirements for animal research, called Good Laboratory Practiceto demonstrate that any scientific data collected in the development of a drug or medical device is reliable, they said Reuters three regulatory experts.

Neuralink cited its animal research data in its FDA application to test the implants in humans. Musk, the company’s billionaire founder, announced in May that his device had been approved for human trials and last month said that the first patient received an implant and was recovering well.

Neuralink did not respond to questions about the FDA visit.

The FDA did not issue its designation indicating the severity of problems found during the inspection, according to the agency’s database. While the problems found are serious, they don’t appear to be significant enough to warrant the FDA’s worst inspection designation, which experts say would prompt action.

Carly Pflaum, an FDA spokesman, said Neuralink “provided sufficient information to support approval” of its application for human testing. The agency routinely conducts these types of inspections, Pflaum said, after human trials are approved and before marketing approval to “ensure data integrity and reliability” and compliance with other FDA regulations.

“The FDA will continue to monitor the safety of subjects enrolled in the Neuralink implant study through mandatory periodic reports,” Pflaum said.

Ryan Merkleydirector of advocacy research at the animal welfare group PCRM, said the FDA should have reviewed Neuralink before approving the human trial, given concerns his organization raised a month ago.

Viktor Krauthamera former longtime FDA official, said the agency has the authority to conduct an inspection before allowing a company to move forward with a clinical trial, and has done so in other cases.

(With information from Reuters)