# FDA 483 - Concha Inc. - March 27, 2026

Source: https://www.keypedia.com/records/483/concha-inc/afabdb3b-9df7-4f5f-a466-548037674ec9

> FDA 483 for Concha Inc. on March 27, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Concha Inc.
- Inspection Date: 2026-03-27
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Concha Inc. in San Mateo, CA, a manufacturer of Concha Sol Hearing Aids, received a Form FDA 483 citing significant deficiencies across its quality management system. The inspection revealed systemic failures in design control, supplier qualification, complaint handling, and critical QMS oversight functions like internal audits and management reviews. These issues indicate a lack of robust processes to ensure device safety and performance throughout development and commercial distribution.

## Related Officers

- [Nga T. Ho](https://www.keypedia.com/people/nga-t-ho/7c7d96a2-9b2c-4966-8dc2-ee20ca024be1)

Company: https://www.keypedia.com/companies/concha-inc/ec42eb8d-247c-4298-b3fd-cd5cd14a4298

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df