Title 21

SECTION 117.257

117.257 Contents of an order to withdraw a qualified facility exemption.

§ 117.257 Contents of an order to withdraw a qualified facility exemption.

An 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(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287;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]

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