Warning letter
OWLET BABY CARE INC: warning letter of Oct 5, 2021
FDA warning letter 616354 · Center for Devices and Radiological Health
Key facts
| Reference number | 616354 |
|---|---|
| Company | OWLET BABY CARE INC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Oct 5, 2021 |
| Posted date | Oct 26, 2021 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Country | 1 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: