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: 21CFR117.139]

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 C - Hazard Analysis and Risk-Based Preventive Controls

Sec. 117.139 Recall plan.

For food with a hazard requiring a preventive control:

(a) You must establish a written recall plan for the food.

(b) The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:

(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;

(2) Notify the public about any hazard presented by the food when appropriate to protect public health;

(3) Conduct effectiveness checks to verify that the recall is carried out; and

(4) Appropriately dispose of recalled food - e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.