Section 117.257 - Contents of an order to withdraw a qualified facility exemptionAn order to withdraw a qualified facility exemption under § 117.5(a) must include the following information:
(a) The date of the order;(b) The name, address, and location of the qualified facility;(c) A brief, general statement of the reasons for the order, including information relevant to one or both of the following circumstances that leads FDA to issue the order: (1) An active investigation of a foodborne illness outbreak that is directly linked to the facility; or(2) Conditions or conduct associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility.(d) A statement that the facility must either:(1) Comply with subparts C and G of this part on the date that is 120 calendar days after the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or(2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 117.264 .(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287 ;(f) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart;(g) A statement that any informal hearing on an appeal of the order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in § 117.270 ;(h) The mailing address, telephone number, email address, fax number, and name of the FDA Division Director in whose division the facility is located (or, in the case of a foreign facility, the same information for the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition); and(i) The name and the title of the FDA representative who approved the order. 80 FR 56145 , Sept. 17, 2015, as amended at 81 FR 3716 , Jan. 22, 2016; 85 FR 16553 , Mar. 24, 2020