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. NCS Pearson - Close Out Letter 7/25/16
  1. Compliance Actions and Activities

CLOSEOUT LETTER

NCS Pearson Jul 25, 2016

NCS Pearson - Close Out Letter 7/25/16


NCS Pearson

  

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

Public Health Service
 Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

JUL 25 2016

Mr. Russell A. Gullotti
CEO and President
Pearson Education, Inc.
NCS Pearson
239 Littleton Road
Suite 6A
Westford, Massachusetts 01886

RE: Quotient ADHD System
Refer to CMS471631

Dear Mr. Gullotti:

The Surveillance and Enforcement Branch II (SEB II), Division of Premarket and Labeling Compliance (DPLC) of the Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions dated September 14, 2015, in response to our Warning Letter dated August 20, 2015. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter and a new 510(k) is not required at this time.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely yours,

/S/

Keisha R. Thomas
Acting Director
Division of Premarket and
   Labeling Compliance
Office of Compliance
Center for Devices and
   Radiological Health
 

cc:
Mr. Mark Yaphe
General Manager
New Business and Innovation
Pearson Clinical Assessment
NCS Pearson
239 Littleton Road
Suite 6A
Westford, Massachusetts 01886