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. Madison Polymeric Engineering - Close Out Letter 10/26/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Madison Polymeric Engineering Oct 26, 2017

Madison Polymeric Engineering - Close Out Letter 10/26/17


Recipient:
Madison Polymeric Engineering


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Medical Devices and Radiological Health Operations (Division-1)
One Montvale Avenue
Stoneham, MA 02180 

 
 

DELIVERED VIA UPS

October 26, 2017

Walter L. Maguire, Jr.
President
Madison Polymeric Engineering
965 West Main Street
Branford, CT 06405

Dear Mr. Maguire:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS Case 456082, issued on April 22, 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 yours,
/S/

Richard Cherry
Compliance Officer
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs