FDA 483 - Happy Health Inc - May 29, 2025
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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.
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- Dallas District Office
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ID · e4803f78-822f-4e40-ad94-b86d5aec7b87