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. Herniamesh S.r.l - Close Out Letter 10/5/16
  1. Warning Letters

CLOSEOUT LETTER

Herniamesh S.r.l


Herniamesh S.r.l

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
 

 

OCT 05, 2016
 

Lorena A. Trabucco
President, U.S. Agent
Herniamesh S.r.l.
540 Muttontown Eastwoods Road
Syosset, New York 11791
 

Dear Ms. Trabucco:
 

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 480085, dated November 23, 2015. Based on our evaluation, it appears that you have addressed the violations 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/

M. lsabel Tejero del Rio, MD PhD
Deputy Director
Division of lnternational Compliance Operations
Office of Compliance
Center for Devices and Radiological Health