U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Apnea Sciences Corporation - 392712 - 04/29/2019
  1. Warning Letters

CLOSEOUT LETTER

Apnea Sciences Corporation MARCS-CMS 392712 —

Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
James Fallon
Recipient Title
CEO
Apnea Sciences Corporation

27121 Aliso Creek Rd
Ste 140
Aliso Viejo, CA 92656-5308
United States

Issuing Office:
Center for Devices and Radiological Health

19701 Fairchild Road
Los Angeles, CA 92612
United States


Dear Mr. Fallon:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #37-13), dated 05/09/2013. 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/
Jeffrey Wooley
(Acting) Compliance Branch Director
FDA/Office of Regulatory Affairs
Office of Medical Device and Radiological Health Operations
Division 3/West Compliance Branch