21 CFR § 117.280 - Revocation of an order to withdraw a qualified facility exemption.

---
identifier: "/us/cfr/t21/s117.280"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 117.280 - Revocation of an order to withdraw a qualified facility exemption."
title_number: 21
title_name: "Food and Drugs"
section_number: "117.280"
section_name: "Revocation of an order to withdraw a qualified facility exemption."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "117"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 56145, Sept. 17, 2015, unless otherwise noted."
cfr_part: "117"
---


# 117.280 Revocation of an order to withdraw a qualified facility exemption.

An order to withdraw a qualified facility exemption is revoked if:

(a) You appeal the order and request an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10-calendar days after the hearing, or issues a decision revoking the order within that time; or

(b) You appeal the order and request an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time; or

(c) You appeal the order without requesting an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time.