FDA Inspection
Happy HealthHappy Health – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Happy Health, with an inspection on September 18, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 5cefbed2-80f4-41a2-b281-b19f065533ca
Inspection Facts
- Inspection number
- 1336882
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- ISO 13485:2016 Clause 5.6.3Management review output not recorded
- ISO 13485:2016 Clause 7.3.6Design and development verification plans not adequate
- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.2.4Internal audit criteria, scope, interval, and methods not defined and recorded
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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