21 CFR §117.257

1. (a)The date of the order;
2. (b)The name, address, and location of the qualified facility;
3. (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. (1)An active investigation of a foodborne illness outbreak that is directly linked to the facility; or
   2. (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.
4. (d)A statement that the facility must either:
   1. (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. (2)Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 117.264.
5. (e)A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287;
6. (f)The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart;
7. (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;
8. (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
9. (i)The name and the title of the FDA representative who approved the order.