The FDA reportedly identified quality-control issues at a Neuralink animal lab shortly after Elon Musk said the startup was cleared to start human tests

Thousands of people have expressed interest in participating in the FDA trial for Neuralink, Bloomberg reported. NurPhoto

• The FDA found some “record keeping and quality controls” issues at a Neuralink animal-testing site, Reuters reported.
• The issues, reportedly discovered at a California facility, were not significant enough to prompt action.
• Elon Musk’s startup said it had successfully implanted its first brain chip in a human in January.

Elon Musk’s Neuralink faced scrutiny from the US Food and Drug Administration shortly after the billionaire said the regulator had approved the startup for human trials of its brain chips, according to a recent report from Reuters.

The publication, citing FDA records, reported that the agency discovered issues with “record keeping and quality controls for animal experiments” at Neuralink’s facility in California, including a lack of records regarding how some tools were properly “calibrated” and individuals involved in ensuring quality control had failed to provide some documentation.

The issues were identified between June 12 and June 22, 2023, Reuters reported. Neuralink had said in May 2023 that it had been cleared by the FDA to begin human trials of its technology, which has since implanted its first brain chip in a person.

The company’s site in Texas did not have the same issues, Reuters reported, citing FDA records.

Despite some of the issues the agency identified at the California site, which handles animal research, Reuters said the FDA has not designated the issues as significant enough to prompt action by the regulator. An FDA spokesperson told Reuters that Neuralink “provided sufficient information to support the approval” of its human testing, but the agency will “continue to monitor the safety of those enrolled in the study for Neuralink’s implant device through required, regular reports.” An FDA spokesperson did not immediately respond to a request for comment from Business Insider ahead of publication.

A spokesperson for Neuralink did not respond to a request for comment from BI or Reuters. The startup was cofounded in 2016 by Elon Musk and aims to surgically implant chips in human skulls that could help people interact with computers using only their mind.

Neuralink also envisions its chips as helping people with paralysis. Musk said the company kicked off human trials earlier this year and successfully implanted its first chip in a patient.

“Progress is good, and the patient seems to have made a full recovery, with neural effects that we are aware of,” Musk said in a X Spaces earlier this month. “Patient is able to move a mouse around the screen by just thinking.”

The startup has faced regulatory scrutiny in the past. In 2022, Reuters reported that the US Department of Agriculture was looking into reports of mistreatment of the animals used in testing the device. Last summer, the agency said it only found one violation and Neuralink had already reported the issue.

Musk’s other companies — driven by the billionaire’s “maniacal sense of urgency” — have also caught the eye of US regulators in recent years. Earlier this week, Bloomberg reported that the Occupational Safety and Health Administration had looked into reports that some workers at The Boring Company had faced chemical burns and accidents amid the company’s push to expand its tunnels in Las Vegas. Last year, a Reuters investigation reported that SpaceX workers were putting in over 80-hour workweeks and facing high injury rates.

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