CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR117.264]

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

Sec. 117.264 Procedure for submitting an appeal.

(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 Office of Compliance in the Center for Food Safety and Applied Nutrition), 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 § 117.5(a), you may include a written request for an informal hearing as provided in § 117.267.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016; 85 FR 16553, Mar. 24, 2020]