FDA 483 - Happy Health Inc - May 29, 2025

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.