U.S. Food and Drug Administration inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.
The inspectors identified quality control lapses at the company’s California animal research facility. A similar inspection at Neuralink’s Texas facility did not find problems, according to agency records.
Those visits took place last year from June 12-22, and represent the FDA’s sole inspections of Neuralink facilities on record. The inspector reports were shared with Reuters by Redica Systems, a data analytics company that obtains FDA compliance reports through open records requests.
“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.
The laboratory problems identified by FDA inspectors included missing calibration records for instruments such as a pH meter used in one of the studies. For another study, seven instruments including a “vital signs monitor” had no record of having been calibrated. Neuralink conducted experiments on hundreds of animals, including monkeys.
The 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 computer device.
Last week, Elon Musk revealed that the first Neuralink patient can control a computer mouse through thinking. The billionaire’s startup says it has developed a brain implant to help humans use their neural signals to control external technologies.
Musk, who is also the CEO of Tesla, said Neuralink is trying to get “as many button presses as possible from thinking” from the patient.
