Exclusive: 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.
https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/
Funny thing, we haven't heard anything from the human patient the implant was placed in either.
