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. Chlodnia Grudziadz Sp. z o.o. - 07/20/2015
  1. Warning Letters


Chlodnia Grudziadz Sp. z o.o.

Chlodnia Grudziadz Sp. z o.o.

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 College Park, 20740 


JUL 20, 2015

Mr. Mieczyslaw Sekula, Director of Production
Chlodnia Grudziadz Sp. Z o.o.
ul. Gen. Jozefa Kustronia 13
NIP: 876-233-01-25, Region 340162937
Grudziadz, 86-300 Poland

Dear Mr. Sekula:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #452181, dated May 12, 2015. Based on our evaluation, you have voluntarily ceased distribution ofthe identified products into the United States. 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.


Carrie J. Lawlor
Branch Chief (Acting)
Labeling and Dietary Supplement
       Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Back to Top