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. Gilchrist & Soames - Close Out Letter 2/20/18
  1. Warning Letters

CLOSEOUT LETTER

Gilchrist & Soames


Recipient:
Gilchrist & Soames


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 
 

February 20, 2018

VIA UPS

Paul Xenis, COO and President
Sysco Guest Supply, LLC
300 Davidson Ave.
Somerset, NJ 08873

Dear Mr. Xenis,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2016-DET-09, dated March 16, 2016. 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/

Byron J. Ho, DVM
Compliance Officer
Human and Animal Food Operations
Division East 6
 

CC:

Donald Turgeon, General Manager and CFO
Gilchrist & Soames
2425 E. Perry Rd
Suite 150
Plainfield, IN 46168