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. Polonica Inc. - Close Out Letter 8/24/15
  1. Warning Letters

CLOSEOUT LETTER

Polonica Inc.


Polonica Inc.

  

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

 
 Food and Drug Administration
New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969

August 24, 2015

VIA UPS OVERNIGHT

Mr. Marek Pyrycz
President and Co-owner
Polonica Inc.
10 Self Boulevard
Carteret, NJ 07008

Dear Pyrycz:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, File Number 12-NWJ-08. 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/

Craig W. Swanson
Acting District Director
New Jersey District