Problems at Elon Musk's Brain Implants Facility Revealed in FDA Investigation

Elon Musk’s Neuralink company was found to have issues with record keeping and quality controls for animal experiments upon a federal inspection.

The problems at the facility were revealed less than a month after the startup was approved to test its brain implants in humans, Knewz.com has learned.

Elon Musk announced his company’s successful brain chip implant last month. By: MEGA

Reuters, which obtained an agency report from the United States Food and Drug Administration, reports that the issues were in a inspection that was done at the company’s animal research facility in California.

Citing agency records, the outlet notes that a similar inspection at Neuralink’s Texas facility did not find issues.

The inspections took place from June 12 to June 22 last year. They are the only times the FDA has reviewed Neuralink’s facilities.

The reports were shared to Reuters through Redica Systems, a data analytics company that obtains FDA compliance reports through open records requests.

Elon Musk hopes to bridge the gap between man and machine. By: Neuralink

“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.

FDA inspectors found that calibration records were missing in the laboratory for instruments such as a pH meter that had been used in experiments. It also found that seven instruments, including a “vital signs monitor,” from another study had no documentation of being calibrated.

Neuralink has done tests on hundreds of animals, including monkeys.

The FDA also found a lack of documentation when it came to final study reports.

“This certainly is a signal that the company needs to be vigilant about certain practices,” Chapman, while noting that the company would need to fix similar protocols for any human testing.

People with paralysis could operate a phone or computer simply by thinking, thanks to an implant device roughly the size of a quarter. Bluetooth technology sends signals from the implant. By: MEGA

The FDA didn’t designate the severity of the problems at Neuralink, suggesting it’s not to the level in which action would be required.

Carly Pflaum, an FDA spokesperson, told Reuters that Neuralink “provided sufficient information to support the approval” of its human testing.

“The FDA will continue to monitor the safety of those enrolled in the study for Neuralink’s implant device through required, regular reports,” Pflaum said.

As Knewz.com reported on January 30, Musk announced his company’s first successful implantation of a brain chip in a human being.

Stephen Hawking was provided special technology to turn his thoughts into speech. By: MEGA

“Promising neuron spike detection,” Elon Musk wrote on X (the name he changed from Twitter) Monday, January 29.

Neuralink conducted the N1 implant surgery on an unidentified patient the previous day. A robot created especially for the operation performed the placement of several chips.

The scientific name for the process is BCI, “brain-computer interface.” Musk calls it Telepathy, and says it’s meant for good.

“Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal,” USA Today quoted Musk as saying.

Elon Musk changed Twitter’s name to X. By: MEGA

People with paralysis could operate a phone or computer simply by thinking, thanks to an implant device roughly the size of a quarter. Bluetooth technology sends signals from the implant.

“I’d say it’s like a Fitbit in your skull,” Musk explained during an online conference in 2021. “This obviously would be a massive enabler, make life way easier for them.”

Another company beat Musk to the first human chip implant. Knewz.com reported in May 2023 on Blackrock Neurotech of Utah putting chip implants in about 50 people.

But Musk is a more famous name because of his connections to X, SpaceX and Tesla.