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CLOSEOUT LETTER

Insightra Medical Inc


Insightra Medical Inc

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
         FAX: 949-608-4415

VIA UNITED PARCEL SERVICE

August 6, 2015

Mr. Brad Sharp, C.E.O.
Insightra Medical, Inc.
9200 Irvine Center Drive, Suite 200
Irvine, CA, 92618-2794

Dear Mr. Sharp:

The Food and Drug Administration has received your responses FDA Warning Letter (WL) #20-15, dated May 21, 2015, including your written responses dated June 10, 2015 and June 17, 2015. Your responses included revised standard operating procedures (SOPs) for: Returned Product Handling and Evaluation; Product Complaint Handling and Post Marketing Surveillance; and associated forms. Your response also included employee training records and copies of MDR Reports, FDA Form 3500A that have been filed.

Based on our evaluation of your corrective actions, it appears you have addressed the violations contained in the Warning Letter you received. We appreciate the corrective actions you have taken. 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/

Alonza E. Cruse, Director
Los Angeles District