CLOSEOUT LETTER

Saputo Dairy Foods USA, LLC February 06, 2017

Recipient:: Saputo Dairy Foods USA, LLC; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office Central Region 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5455 Fax: (410) 779-5705

Monday, February 6, 2017

VIA UPS

WARNING LETTER CLOSE-OUT LETTER

Mr. Lino A. Saputo Jr., CEO and President
Saputo, Inc.
6869, Metropolitain, East
Montréal Qc H1P 1X8
Canada

Dear Mr. Saputo:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated March 17, 2016 (CMS # 481087). 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/

Ernest F. Bizjak
Compliance Officer
Baltimore District

CC:
Mr. Steven A. Park, Plant Manager
Saputo Dairy Foods USA, LLC
428 E Patrick St
Frederick, MD 21701-5730

Department of Health and Human Services