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  5. Owlet Baby Care, Inc. - 616354 - 06/05/2024
  1. Warning Letters

CLOSEOUT LETTER

Owlet Baby Care, Inc. MARCS-CMS 616354 —

Product:
Medical Devices
Recipient:
Recipient Name
Mr. Kurt Workman
Recipient Title
Chief Executive Officer
Owlet Baby Care, Inc.

3300 N. Ashton Blvd
Suite 300
Lehi, UT 84043
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Secondary Issuing Offices

United States

Dear Mr. Workman:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 616354, dated October 5, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
for Malvina B. Eydelman, M.D.
Director
OHT 1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Center for Devices and Radiological Health

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