# FDA 483 - Nalu Medical, Inc. - April 28, 2021

Source: https://www.keypedia.com/records/483/nalu-medical-inc/d5633733-1b28-400a-9cfc-d50b70399990

> FDA 483 for Nalu Medical, Inc. on April 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nalu Medical, Inc.
- Inspection Date: 2021-04-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Nalu Medical, Inc. in Carlsbad, CA, a manufacturer of the Nalu Neurostimulation System, revealed two significant observations. The firm failed to adequately validate device software, specifically a compiler tool, despite its risk classification. Additionally, procedures for corrective and preventive actions were found to be inadequately established and implemented, with multiple open and delayed CAPA and complaint investigations.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/nalu-medical-inc/deb4eb8b-5463-415f-956c-57b543d021eb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6