GroundRules
21 CFR 507.69: Procedure for submitting an appeal.
Where this section sits in the code
- 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
(a) To appeal an order to withdraw a qualified facility exemption, you must:
(1) Submit the appeal in writing to the FDA Division Director in whose division the facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), at the mailing address, email address, or fax number identified in the order within 15 calendar days of the date of receipt of confirmation of the order; and
(2) Respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which you rely.
(b) In a written appeal of the order withdrawing an exemption provided under § 507.5(d), you may include a written request for an informal hearing as provided in § 507.71.
Collected 2026-08-27T02:24:47Z. Source file · JSON