# FDA 483 - Neuralink Corporation - June 22, 2023

Source: https://www.keypedia.com/records/483/neuralink-corporation/f5c98dcb-b063-40d9-a9af-b486ea2608ee

> FDA 483 for Neuralink Corporation on June 22, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuralink Corporation
- Inspection Date: 2023-06-22
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Neuralink Corporation, a nonclinical laboratory in Fremont, CA, revealed significant deficiencies in record-keeping and quality assurance practices. The firm failed to maintain adequate documentation for equipment maintenance and calibration, impacting multiple studies and instruments. Additionally, final study reports lacked required Quality Assurance Unit statements, and the QAU did not properly document deviations from approved protocols, including water quality testing.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)
- [Hugh M. Mcclure](https://www.keypedia.com/people/hugh-m-mcclure/e69b7562-8fb5-4b7d-a506-a9bc0f0e9e43)
- [investigator](https://www.keypedia.com/people/scott-b-laufenberg/ff95c69f-5ee2-4761-b4ef-8b8137c3d963)

Company: https://www.keypedia.com/companies/neuralink-corporation/70d52890-0416-40b6-8e44-e174068144f8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b