# FDA 483 - Happy Health Inc - May 29, 2025

Source: https://www.keypedia.com/records/483/happy-health-inc/e4803f78-822f-4e40-ad94-b86d5aec7b87

> FDA 483 for Happy Health Inc on May 29, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Happy Health Inc
- Inspection Date: 2025-05-29
- Product Type: other
- Office Name: Dallas District Office
- Summary: Happy Health Inc, a sponsor in Austin, TX, was cited for multiple deficiencies during an inspection of its clinical study conducted from 2023-2024. Observations included failures in obtaining proper informed consent, lacking written procedures for monitoring an investigational device study, and omissions of required statements in informed consent documents. These issues indicate non-compliance with regulations for human subject protection and investigational device studies.

## Related Officers

- [Iris C. Macinnes](https://www.keypedia.com/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)

Company: https://www.keypedia.com/companies/happy-health-inc/7464e053-9251-4fe7-835e-9932fd28c452

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9