CLOSEOUT LETTER
Gilchrist & Soames MARCS-CMS 485833 —
- Recipient:
- Gilchrist & Soames
United States
- Issuing Office:
United States
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Chicago District Office |
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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