Musk's Neuralink brain implant company cited by FDA over animal lab issues

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, opens new tab, 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.

The laboratory problems identified by FDA inspectors included missing calibration records for instruments such as a pH meter used in one of the studies. For another study, seven instruments including a "vital signs monitor" had no record of having been calibrated. Neuralink conducted experiments on hundreds of animals, including monkeys.

Other issues included quality assurance officials not signing off on the final study report or documenting any deviations from approved protocols or standard operating procedures.

"This certainly is a signal that the company needs to be vigilant about certain practices," said Chapman, adding that the company would be required to follow similar practices for its human trials.

The brain implant is being tested to help patients paralyzed by spinal cord injury or amyotrophic lateral sclerosis