# FDA 483 - Theos Medical Systems, Inc. - June 16, 2023

Source: https://www.globalkeysolutions.net/records/483/theos-medical-systems-inc/60265961-066d-4fbe-a51e-95e12daa940c

> FDA 483 for Theos Medical Systems, Inc. on June 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theos Medical Systems, Inc.
- Inspection Date: 2023-06-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA inspected Theos Medical Systems, Inc. in Santa Clara, CA, and issued a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate complaint handling, a lack of documented corrective and preventive actions, and a failure by management to effectively maintain the quality system through data analysis. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance.

## Related Officers

- [Christopher W. Buser](https://www.globalkeysolutions.net/people/christopher-w-buser/6a11d2e7-dcfa-4542-ba81-b4c6b244ef04)

Company: https://www.globalkeysolutions.net/companies/theos-medical-systems-inc/5c91cd12-9e3f-44d8-b416-a5188ced6b1c

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