Device establishmentActive, RegisteredFDA warning letter on file
OWLET BABY CARE
OWLET BABY CARE is an FDA-registered device establishment (FEI 3012977166) located in Lehi, Utah. The facility is active, registered. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is OWLET BABY CARE registered with the FDA?
Yes. OWLET BABY CARE is an FDA-registered device establishment (FEI 3012977166) in Lehi, Utah. Its current registration status is Active, Registered.
Has OWLET BABY CARE received an FDA warning letter?
Yes. FDA issued a warning letter to OWLET BABY CARE; the most recent is dated Oct 5, 2021 (Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device).
What does OWLET BABY CARE do?
OWLET BABY CARE's FDA-registered operations are: Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198.
Related facilities
Source: FDA public data · status as of 2026-08-22