- Chlodnia Grudziadz Sp. z o.o.
Department 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
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition