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. Intershell International Corp. - Close Out Letter 2/4/15
  1. Warning Letters

CLOSEOUT LETTER

Intershell International Corp.


Intershell International Corp.

  

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

 
 Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

February 4, 2015


Ms. Yibing-Gau Rome, President
Intershell International Corp.
9 Blackburn Drive
Gloucester, MA 01930-2237


Dear Ms. Rome:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS 440205, September 26, 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/

Amber Wardwell
Director Compliance Branch
New England District