# FDA 483 - Sotera Wireless, Inc. - June 19, 2026

Source: https://www.keypedia.com/records/483/sotera-wireless-inc/41815ec0-732c-4759-a813-b83b76080a36

> FDA 483 for Sotera Wireless, Inc. on June 19, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sotera Wireless, Inc.
- Inspection Date: 2026-06-19
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Sotera Wireless, Inc., a Class II medical device manufacturer in San Diego, CA, revealed two significant observations. The firm failed to provide justification for not reporting a correction or removal action to the FDA, specifically regarding a complaint about their Visi Mobile Monitoring System. Additionally, procedures for corrective and preventive actions were found to be inadequately established, with an open CAPA not being investigated or closed in a timely manner.

## Related Officers

- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/sotera-wireless-inc/fa783d65-c9ac-4c6e-a0e9-00eca02eb69f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face