Code of Federal Regulations Title 21. Food and Drugs § 21.117.264 Procedure for submitting an appeal

(1) Submit the appeal in writing to the FDA Division Director in whose division the facility is located (or, in the case of a foreign facility, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), at the mailing address, email address, or fax number identified in the order within 15 calendar days of the date of receipt of confirmation of the order;  and

(2) Respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which you rely.