subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "507"
part_subject: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS"
subpart_code: "C"
subpart_subject: "Hazard Analysis and Risk-Based Preventive Controls"
section_number: "507.40"
section_subject: "Monitoring."
cfr_reference: "21 CFR 507.40"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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As appropriate to the nature of the preventive control and its role in the facility's food safety system you must:
(a)Establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls; and
(b)Monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.
(1)You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with § 507.45(a)(2) and records review in accordance with § 507.49(a)(4)(i);
(i)Records of refrigeration temperature during storage of animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control; and
(ii)Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.