Neuralink brain technology company was found to have «objectionable conditions or practices» by the Food and Drug Administration, which cited the company and urged it to address the problems.
FDA inspectors identified the issues at Neuralink's animal testing facilities in California in June 2023, several weeks after the agency had given the company the green light for a small study of its brain implant in humans, according to the letter to Congress dated November 29.
The agency was responding to concerns raised by Earl Blumenauer, a House Democrat from Oregon who has focused on animal welfare.
The FDA told Blumenauer the issues found at Neuralink warranted voluntary remediation measures by the company. They were not considered severe enough to require regulatory action by the agency.
«While the company did receive citations related to documentation of its animal research, the FDA's inspection did not find evidence of any violations that would undermine the device's safety,» the FDA said in a statement in response to questions from Reuters. It did not provide further details of the areas of concern.
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