21 CFR § 117.206 - Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.

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§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.

(a) If a facility that is solely engaged in the storage of unexposed packaged food stores any such refrigerated packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by pathogens, the facility must conduct the following activities as appropriate to ensure the effectiveness of the temperature controls:

(1) Establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin production by, pathogens;

(2) Monitor the temperature controls with adequate frequency to provide assurance that the temperature controls are consistently performed;

(3) If there is a loss of temperature control that may impact the safety of such refrigerated packaged food, take appropriate corrective actions to:

(i) Correct the problem and reduce the likelihood that the problem will recur;

(ii) Evaluate all affected food for safety; and

(iii) Prevent the food from entering commerce, if you cannot ensure the affected food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act;

(4) Verify that temperature controls are consistently implemented by:

(i) Calibrating temperature monitoring and recording devices (or checking them for accuracy);

(ii) Reviewing records of calibration within a reasonable time after the records are created; and

(iii) Reviewing records of monitoring and corrective actions taken to correct a problem with the control of temperature within 7 working days after the records are created or within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 7 working days;

(5) Establish and maintain the following records:

(i) Records (whether affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control) documenting the monitoring of temperature controls for any such refrigerated packaged food;

(ii) Records of corrective actions taken when there is a loss of temperature control that may impact the safety of any such refrigerated packaged food; and

(iii) Records documenting verification activities.

(b) The records that a facility must establish and maintain under paragraph (a)(5) of this section are subject to the requirements of subpart F of this part.

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