Shortly after signing off on the first human trial of Neuralink’s brain-computer interface system last year, the FDA reportedly discovered a handful of quality control issues related to the Elon Musk-founded company’s animal experiments of the technology.
According to an agency report obtained by regulatory intelligence firm Redica Systems and shared with Reuters, FDA inspectors spotted multiple issues at Neuralink’s animal research facility in California during a series of visits in mid-June 2023.
The issues reportedly did not stretch to Neuralink’s Texas facility.
The FDA’s inspection looked into experiments Neuralink conducted on monkeys and other animals to prepare its brain-computer interface for implantation on human brains—with the first such implants slated to translate the neurological signals of people with paralysis into actions on a computer.
According to Reuters, the report shows that inspectors were unable to locate required calibration records for pH meters, vital signs monitors and other devices used in animal tests. In another case, Neuralink quality assurance officials had reportedly failed to sign off on final study reports and highlight any areas where the actual experiments had deviated from preset approved protocols.
Experts told the outlet that while those issues are serious, they may not be severe enough for the FDA to hand down an inspection designation that would require corrective actions.
“These issues show a lack of attention to detail,” Jerry Chapman, a senior quality expert with Redica, told Reuters. “This certainly is a signal that the company needs to be vigilant about certain practices.”
Neuralink did not reply to requests for comment from either Fierce Medtech or Reuters.
The news of the FDA’s inspection is just the latest in an ongoing saga of animal-testing-related troubles for Neuralink.
In early 2022, the Physicians Committee for Responsible Medicine, an advocacy group, filed a complaint with the U.S. Department of Agriculture (USDA) in which it accused Neuralink of treating its animal subjects inhumanely and causing the unnecessary deaths of several of the animals.
Neuralink denied the allegations, arguing that its animal care program allows its subjects’ lives to be “as vital and naturalistic as possible.”
By the end of that year, however, the USDA had opted to open a probe into the company’s treatment of animals. In an update last summer, per Reuters, USDA Secretary Thomas Vilsack wrote in a letter to Oregon Congressman Earl Blumenauer that the agency had found no evidence of violations of animal welfare rules in its inspections of Neuralink facilities so far, though more inspections were planned.