In a recent report, FDA inspectors uncovered deficiencies in record-keeping and quality controls for animal experiments at Elon Musk’s Neuralink.
This revelation comes less than a month after Neuralink announced clearance to proceed with human testing for its brain implants.
Jerry Chapman, a senior quality expert with Redica Systems, a data analytics company specializing in FDA compliance reports, expressed concern, stating that the identified problems indicate a “lack of attention to detail” at Neuralink.
The FDA inspectors flagged issues such as missing calibration records for instruments used in studies and Neuralink’s experiments on hundreds of animals, including monkeys.
The inspection focused on the company’s California animal research facility, revealing quality control lapses, while a similar inspection at Neuralink’s Texas facility found no issues, Reuters reported, citing FDA records from visits conducted in June last year.
Chapman emphasized that the highlighted problems should serve as a signal for Neuralink to be vigilant about certain practices, especially as the company moves into human trials.
These trials aim to test the brain implants designed to assist patients paralyzed by spinal cord injuries or conditions like amyotrophic lateral sclerosis in communicating through thoughts to control computer devices.
The FDA inspection also follows reports from December 2022 that the U.S. Department of Agriculture (USDA) was investigating potential animal welfare violations at Neuralink.
The Physicians Committee for Responsible Medicine submitted a formal complaint to the USDA and FDA over alleged breaches.
While Neuralink’s animal research data was cited in its FDA request for human trials, concerns about the rushed nature of animal testing had been raised internally.
Citing an FDA spokesperson, Carly Pflaum, Reuters mentioned that Neuralink provided sufficient information to support human trial approval and routine inspections are conducted post-approval to ensure data integrity and compliance with FDA regulations.
However, critics argue that the FDA should have conducted the inspection before approving human trials, given concerns raised months earlier.
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