{"data":{"id":"us/21-cfr-117.257","jurisdiction":"us","citation":"21 CFR 117.257","heading":"Contents of an order to withdraw a qualified facility exemption.","body":"An order to withdraw a qualified facility exemption under § 117.5(a) must include the following information:\n(a) The date of the order;\n(b) The name, address, and location of the qualified facility;\n(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:\n(1) An active investigation of a foodborne illness outbreak that is directly linked to the facility; or\n(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.\n(d) A statement that the facility must either:\n(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\n(2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 117.264.\n(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 117.287;\n(f) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart;\n(g) A statement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;\n(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\n(i) The name and the title of the FDA representative who approved the order.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION","PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD","Subpart E—Withdrawal of a Qualified Facility Exemption"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"a1ffe70d9ca05559df1d258cdfcaca5dcfb824a009fe5046df97b24288989c0d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-117.254","next":"us/21-cfr-117.260"},"notice":"GroundRules: Original legal text. Not legal advice."}