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. Impladent Ltd. - Close Out Letter 1/5/16
  1. Warning Letters

CLOSEOUT LETTER

Impladent Ltd.


Impladent Ltd.

  

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

January 5, 2016


Mr. Maurice Valen
CEO
Impladent, Ltd.
198-45 Foothill Avenue
Hollis, New York 11423


Dear Mr. Valen:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated March 28, 2014. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.

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, 21 U.S.C. § 321(h), 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/

James Saviola, OD, CAPT USPHS
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
   Radiological Health