CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR117.126]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

Subpart C - Hazard Analysis and Risk-Based Preventive Controls

Sec. 117.126 Food safety plan.

(a) Requirement for a food safety plan. (1) You must prepare, or have prepared, and implement a written food safety plan.

(2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.

(b) Contents of a food safety plan. The written food safety plan must include:

(1) The written hazard analysis as required by § 117.130(a)(2);

(2) The written preventive controls as required by § 117.135(b);

(3) The written supply-chain program as required by subpart G of this part;

(4) The written recall plan as required by § 117.139(a); and

(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a);

(6) The written corrective action procedures as required by § 117.150(a)(1); and

(7) The written verification procedures as required by § 117.165(b).

(c) Records. The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part.

[80 FR 56145, Sept. 17, 2015, as amended at 84 FR 12491, Apr. 2, 2019]