FDA Inspection
Happy Health IncHappy Health Inc – FDA Inspection, May 29, 2025
Record Details
This FDA Inspection record concerns Happy Health Inc, with an inspection on May 29, 2025, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 2fc1e2e4-2bcf-4868-917b-9e2ae75c0f84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271068
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
5- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
- 21 CFR 812.25(e)Sponsor's lack of written monitoring procedures
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