{"data":{"id":"us/21-cfr-507.65","jurisdiction":"us","citation":"21 CFR 507.65","heading":"Contents of an order to withdraw a qualified facility exemption.","body":"An order to withdraw a qualified facility exemption under § 507.5(d) 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 animal 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 E 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the requirements of § 507.69.\n(e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 507.85;\n(f) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart;\n(g) A statement that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 § 507.73;\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 Division of Compliance in the Center for Veterinary Medicine); 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 E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS","PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS","Subpart D—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":"33c40ad1c5ae998363d14bde681c09f4f15294fec89d5b531697931b8269f427","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-507.62","next":"us/21-cfr-507.67"},"notice":"GroundRules: Original legal text. Not legal advice."}