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Title 21: Food and Drugs
§ 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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