Reuters reports that FDA inspectors identified issues with record keeping and quality controls for animal experience at Neuralink.
This isn’t the first time questions have been raised over the Elon Musk-backed brain-computer interface company’s animal practices. Over the past couple of years, the company has drawn concerns over animal welfare and hazardous material transport practices.
Reuters‘ report comes amid the company’s first-in-human trial for its brain implant, a trial approved by the FDA in May. Just last week, Musk said that the first patient to receive the Neuralink implant fully recovered and can control a computer mouse using their thoughts. Musk claimed that “progress is good and the patient seems to have made a full recovery with no ill effects that we are aware of.”
According to the report, the FDA flagged the issues after a visit to Neuralink’s California animal research facility in June. Reuters says a similar inspection at the company’s Texas plant presented no such issues, though. The outlet said Redica Systems shared the reports from the FDA visits. Redica obtains FDA compliance reports through open records requests. Reuters says that a Redica official says the FDA report highlights a lack of attention to detail at Neuralink.
Issues identified include missing calibration records for instruments like a pH meter used in Neuralink studies, the report said. Additionally, in another study, seven instruments — including a vital signs monitor — had no record of calibration. Other issues included no sign-off from quality assurance officials on final study reports or protocol deviation documentation.
According to Reuters, the FDA has not yet officially designated the severity of the issues at Neuralink. The outlet says the issues “don’t appear significant enough” to bring about action from the agency.