FILE PHOTO: A smartphone with a Neuralink logo displayed is placed on a computer motherboard in this illustration taken on May 15, 2024. REUTERS/Dado Ruvic/Illustration/File Photo
(Reuters) - An animal testing laboratory at Elon Musk's 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 Nov. 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.
Reuters reported in February that FDA inspectors had found problems with quality controls and record keeping at Neuralink's lab in California during a June 2023 inspection, but had yet to determine what degree of action was warranted.
The FDA declined to say whether these were the same objectionable conditions cited in the letter.
Neuralink did not respond to a request for comment about whether it had fixed any of the problems identified by the FDA. The company has said it goes above and beyond existing regulations in its treatment of animals for testing.
A spokesperson for Blumenauer declined to comment.
Reuters also reported in 2022 about internal staff complaints that Neuralink rushed experiments, causing the needless suffering and deaths of pigs, monkeys and other animals.
Neuralink is one of several companies that aim to help patients with paralysis, blindness and other disorders to interact with the world, using a brain chip to translate their thoughts into digital communication.
The company has so far implanted its device in two U.S. patients, and plans a similar study in Canada.
Musk has been tasked by President-elect Donald Trump with slashing government spending at federal agencies such as the FDA.
His role leading the newly created "Department of Government Efficiency" may help insulate his own companies from regulation or enforcement and boost their government support, Reuters reported last month.
(Reporting by Rachael Levy in Washington D.C.; Editing by Lincoln Feast.)
