The Food and Drug Administration (FDA) has cited Elon Musk’s brain technology company, Neuralink, for “objectionable conditions or practices” at its animal testing facilities. The issues were identified during a June 2023 inspection, which took place shortly after the FDA had approved a small human study of Neuralink’s brain implant. The agency urged the company to address these problems but noted that they did not warrant immediate regulatory action.
FDA inspectors raised concerns over the documentation and quality control practices at the laboratory, though no violations were found that would undermine the safety of the company’s device. These issues were considered serious enough to warrant voluntary remediation measures, but not severe enough to require formal regulatory intervention.
The investigation followed concerns raised by Earl Blumenauer, a U.S. House Democrat from Oregon, who has focused on animal welfare. While the FDA declined to disclose specific details of the identified issues, it did clarify that the company had been cited for inadequate record-keeping in its animal research.
Neuralink has faced previous scrutiny for its treatment of animals. In 2022, Reuters reported internal staff complaints alleging that the company rushed experiments, resulting in unnecessary suffering and deaths of animals, including pigs and monkeys. The company, which is developing brain implants to help patients with paralysis, blindness, and other disorders, has stated that it adheres to rigorous animal welfare standards.
Despite these ongoing concerns, Neuralink has successfully implanted its device in two U.S. patients and plans to expand its studies internationally, including in Canada.
The FDA’s response comes at a time when Neuralink’s operations are under greater scrutiny, especially with Musk’s role in the newly established “Department of Government Efficiency.” This position could potentially influence government oversight and regulation of Musk’s companies, raising questions about the future of regulatory enforcement.
