C.F.R. » Title 21 » 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

21 C.F.R. § 117.126

Food safety plan

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(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]
Notes of Decisions
Cited in 1 case, 2018–2018 · leading case: Jack L. Marchand II v. John W. Barnhill, Jr. (Blue Bell Creameries USA, Inc.) (Del. Ch. 2018).
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Jack L. Marchand II v. John W. Barnhill, Jr. (Blue Bell Creameries USA, Inc.) (Del. Ch. 2018). “103 21 C.F.R. § 117.126 . See also 21 U.S.C. § 331 (prohibiting the introduction of adulterated food into interstate commerce); 21 U.”
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