FDA Inspection 1271068 — Happy Health Inc
The FDA completed an inspection of Happy Health Inc on May 29, 2025 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 29, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Austin, TX (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |