CLOSEOUT LETTER

Stewart Brothers, Inc. November 27, 2015

Recipient:: Stewart Brothers, Inc.; United States

Issuing Office:: United States


Department of Health and Human Services
	Food and Drug Administration Seattle District Pacific Region 22215 26th Avenue SE, Suite 210 Bothell, WA 98021-4425 Telephone: 425-302-0340 FAX: 425-302-0402

November 27, 2015

Ronald T. Stewart, President and Owner
Stewart Brothers, Inc.
3610 Central Vale Road
Hood River, Oregon 97031

Dear Mr. Stewart:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 15-11, dated March 25, 2015. Based on our evaluation, it appears 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 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 actions should violations be observed during a subsequent inspection or through other means.

Sincerely,

/S/

Miriam R. Burbach
District Director

cc: James D. Stewart, Secretary and Owner
     Stewart Brothers, Inc.
     3610 Central Vale Road
     Hood River, Oregon 97031

Department of Health and Human Services