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  1. Warning Letters

CLOSEOUT LETTER

H & W Farms LLC MARCS-CMS 518122 —

Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Timothy E. Heffron
Recipient Title
President
H & W Farms LLC

13375 Belding Road, NE
Belding, MI 48809-9383
United States

Issuing Office:
Office of Human and Animal Food Division East 6

550 W. Jackson Blvd
Suite 1500
Chicago, IL 60661
United States

(312) 353-5863

Dear Mr. Heffron,

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (2017-DET-03, dated March 22, 2017). 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 Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6