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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2018]
[CITE: 21CFR117.140]



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. 117.140 Preventive control management components.

(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under 117.135 are subject to the following preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system:

(1) Monitoring in accordance with 117.145;

(2) Corrective actions and corrections in accordance with 117.150; and

(3) Verification in accordance with 117.155.

(b) The supply-chain program established in subpart G of this part is subject to the following preventive control management components as appropriate to ensure the effectiveness of the supply-chain program, taking into account the nature of the hazard controlled before receipt of the raw material or other ingredient:

(1) Corrective actions and corrections in accordance with 117.150, taking into account the nature of any supplier non-conformance;

(2) Review of records in accordance with 117.165(a)(4); and

(3) Reanalysis in accordance with 117.170.

(c) The recall plan established in 117.139 is not subject to the requirements of paragraph (a) of this section.

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