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. Excelsior Medical LLC - Close Out Letter 12/7/16
  1. Warning Letters

CLOSEOUT LETTER

Excelsior Medical LLC


Excelsior Medical LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054 

VIA UNITED PARCEL SERVICE

December 7, 2016

Mr. John M. Linfante
Vice President of Regulatory Affairs/Quality Assurance
Excelsior Medical Corporation
1933 Heck Avenue
Neptune, NJ 07753

Dear Mr. Linfante:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [15-NWJ-03], issued on November 7, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Stephanie Durso
Acting Director of Compliance