# FDA 483 - MRIAUDIO, INC. - September 05, 2025

Source: https://www.globalkeysolutions.net/records/483/mriaudio-inc/4e7bda28-e21d-46cf-9d51-b8afac6c4229

> FDA 483 for MRIAUDIO, INC. on September 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRIAUDIO, INC.
- Inspection Date: 2025-09-05
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: MRIAUDIO, INC. in Carlsbad, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate complaint handling procedures, a complete lack of established design control procedures, and failures in document control and record management. These issues indicate a broad breakdown in critical quality system processes.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/mriaudio-inc/87d3b933-e197-4db9-8ae4-87907c077d6e

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b