U.S. Food and Drug Administration inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.

The inspectors identified quality control lapses at the company’s California animal research facility. A similar inspection at Neuralink’s Texas facility did not find problems, according to agency records.

Those visits took place last year from June 12-22, and represent the FDA’s sole inspections of Neuralink facilities on record. The inspector reports were shared with Reuters by Redica Systems, a data analytics company that obtains FDA compliance reports through open records requests.

“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.

  • JoBo
    8·
    10 months ago

    In July, the USDA said it did not find any violations of its animal research rules beyond a 2019 incident that Neuralink had already reported. ‘VIOLATIONS OF FUNDAMENTAL REQUIREMENTS’

    The FDA has its own requirements for animal research, known as Good Laboratory Practice, to demonstrate that any scientific data being collected in the development of a drug or medical device is reliable, three regulatory experts told Reuters.

    Neuralink cited its animal research data in its FDA request to test the implants in humans. Musk, the company’s billionaire founder, announced in May that his device was cleared for human trials, and said last month the first patient had received an implant and was recovering well.

    So, the USDA inspection is entirely irrelevant wrt to research integrity. USDA is about animal welfare, the FDA is about whether health-related claims made by commercial companies are based on reliable evidence rather than cherry-picking and/or hand-waving.

    I do not understand how the FDA managed to approve human trials before it inspected the facilities. That might be reasonable with a company that had gone through this process before but it is a horrible decision for a company which has never done anything like this before.

    IIRC FDA approval was initially denied and I haven’t seen anything that explains what changed in between denial and approval. But it is worth noting that the FDA is not well-equipped to resist commercial pressure.

    Definitely one to watch.