Warning letter
Happiest Baby, Inc.: warning letter of Jun 15, 2026
FDA warning letter 718306 · Center for Devices and Radiological Health
Key facts
| Reference number | 718306 |
|---|---|
| Company | Happiest Baby, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 15, 2026 |
| Posted date | Jun 15, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.4, 806, 806.10, 807.81(a)(3), 807.81(a)(3)(i), 807.81(a)(3)(ii), 806.10(a), 806.10(b), 807.81(b), 820, 880.5690 |
| Inspection city | Los Angeles |
| Inspection ZIP | 90064 |
| Inspection start date | Jul 21, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: