Neuralink, the brain technology firm led by Elon Musk, has been cited by the Food and Drug Administration (FDA) for “objectionable conditions or practices” at its animal testing laboratory in California, Reuters reported.
This notice follows the company’s approval for a human brain implant study. The FDA’s discovery of the issues occurred in June 2023, shortly after Neuralink was permitted to conduct a limited study on its brain implant technology in humans.
The concerns regarding the animal testing facility were addressed in a letter to Congress on November 29, responding to issues raised by Representative Earl Blumenauer, an advocate for animal welfare from Oregon.
The FDA has urged Neuralink to implement voluntary corrective actions to remedy the conditions found. The agency has indicated that the issues, while warranting citations, were not significant enough to necessitate regulatory action. The FDA emphasized that the inspection did not reveal any violations that would compromise the safety of Neuralink’s devices.
In a statement, the FDA clarified that the citations were related to the documentation of animal research but did not specify the nature of the concerns. The agency’s inspection report from June 2023 had previously noted quality control and record-keeping issues at the facility, although it was unclear at the time what level of action would be required.
Neuralink has not publicly commented on whether it has addressed the FDA’s findings. The company has previously stated that its animal testing protocols exceed the requirements of current regulations.
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