Elon Musk's Neuralink Lab Issued a Warning by the FDA Due to Conditions - Report

According to reports, Neuralink, the brain technology company led by Elon Musk, has been warned by the Food and Drug Administration (FDA) regarding "actionable conditions or practices" at its animal testing laboratory in California. This warning came after the company received approval for its human brain implant studies. The FDA's identification of issues occurred shortly after Neuralink was permitted to conduct limited studies of its brain implant technology on humans, happening in June 2023.

Concerns regarding the animal testing facility were addressed in a letter sent to Congress on November 29. This letter was in response to issues raised by animal welfare advocate Representative Earl Blumenauer from Oregon. The FDA encouraged Neuralink to take voluntary corrective measures to address the identified conditions. The agency noted that while the issues warranted a warning, they were not significant enough to require regulatory action. The FDA emphasized that the inspection did not reveal any violations that would compromise the safety of Neuralink's devices.

In its statement, the FDA indicated that the warnings were related to the documentation of animal research, but did not provide details about the nature of the concerns. The agency's audit report from June 2023 had previously pointed out quality control and record-keeping issues at the facility, but at that time, it was unclear what level of action would be required.

Neuralink has not yet made a public statement regarding whether it has addressed the FDA's findings. The company previously stated that its animal testing protocols exceeded the requirements of existing regulations.