Inspectors from the U.S. Food and Drug Administration (FDA) raised concerns about how animal welfare at Neuralink was being assessed and documented during an inspection of the brain chip startup’s California laboratory, according to agency documents reviewed by Decrypt.
The Elon Musk-owned company failed to produce myriad materials related to the maintenance of scientific equipment, hygiene, and animal welfare at its Fremont laboratory during an FDA inspection in June, according to an agency report shared with Decrypt by Redica Systems.
Redica is a regulation-focused data analytics platform that obtains federal government reports via public records requests.
During the FDA’s visit to Neuralink’s Fremont lab last summer, inspectors voiced some concerns about animal welfare, which centered on a lack of requisite documentation related to animal living conditions. For a two year period spanning 2021 and 2022, Neuralink failed to provide any documentation related to the calibration and maintenance of its “vital signs monitor.”
The startup could also not provide any documentation from 2022 that it conducted water quality tests, as Laboratory Animal Care Program procedure requires.
But, evidently, the FDA’s findings were not sufficient to prompt the agency to reject Neuralink’s request to proceed with human trials.
The documented problems at Neuralink came just weeks after Elon Musk said that the company had received approval from the FDA to begin human trials. The firm is attempting to create implantable brain chips for direct human-machine control and interaction.
Just last month, Musk announced that Neuralink had successfully implanted a computer chip in its first human subject.
Questions surrounding practices at the neurotech startup have swirled for years. Since 2018, the company has killed roughly 1,500 animals in the process of trying to connect brains to computer interfaces.
Records from the California Primate Research Center revealed last year that several monkeys who died after receiving a Neuralink chip implant suffered immensely post-surgery, with some pulling wires out of their own head out of fear and discomfort before being euthanized by Neuralink employees.
Decrypt reached out to the FDA but did not immediately receive a response. Representatives for Neuralink also did not immediately respond to a request for comment.
Edited by Ryan Ozawa.