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Elon Musk's company Neurlink has come under investigation for problems with record-keeping and quality controls for animal experiments less than a month after starting human trials.
The Food and Drug Administration (FDA) identified loopholes and problems at the company's animal research facility in California, which was previously criticized for a "failed test" of the brain chip on monkeys, highlighting the company's readiness for human trials.
Last year's inspections took place from June 12 to June 22, and FDA inspectors found a list of problems including lapses in quality control at the Neurlink laboratory in New York, and missing calibration records for important instruments, such as the pH meter used in one study and a monitoring vital signs,
A similar inspection at a Neurlink facility in Texas found no problems, according to FDA records.
Neurlink has conducted experiments on hundreds of animals, such as pigs, sheep, mice and rats, in addition to monkeys.
The report comes days after Musk announced that the first person to receive a Neuralink implant has recovered and can move a computer mouse cursor with his mind.
The US Food and Drug Administration visits, which took place last year, are the only recorded inspections of the company's two facilities.
It is noteworthy that the majority of problems identified by FDA inspectors relate to basic laboratory rules regarding the proper use of equipment.
“Failed experiments” on monkeys reportedly left the animals alive while suffering brain hemorrhages, according to reports dating back to December 2022 — months before the FDA inspection.
While Musk was urging his employees to make progress in testing the brain chip, the neurosurgeon allegedly used a much larger amount of bioglue than was required, and the adhesive leaked into the monkey's skull, causing its brain to bleed.
"There was no reason to use glue on the monkey's skull during surgery," a former Neuralink employee said in 2022.
Lab employees allegedly "kept suffering animals alive for no reason, and their misconduct caused the monkeys' brains to bleed," according to notes from the lab and a former Neuralink employee. All animals used in the tests were sacrificed.
Three regulatory experts told Reuters that the US Food and Drug Administration has its own requirements for animal research, known as good laboratory practice, to prove that any scientific data collected in the development of a drug or medical device can be relied upon.
The FDA has not issued its final rating indicating the severity of the problems found in the inspection, according to the agency's database.
Experts said that while the identified problems are serious, they do not appear significant enough for the FDA to classify them as the worst, which could prompt action.
Carly Pflum, an FDA spokeswoman, said Neuralink "has provided sufficient information to support approval" of its application for human trials.
English (US)