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§ 507.55 - Implementation records required for this subpart.

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You must establish and maintain the following records documenting implementation of the food safety plan:

Documentation, as required by § 507.36(b), of the basis for not establishing a preventive control in accordance with § 507.36(a);

Records that document the monitoring of preventive controls;

Records that document corrective actions;

Records that document verification, including, as applicable, those related to:

Validation;

Verification of monitoring;

Verification of corrective actions;

Calibration of process monitoring and verification instruments;

Product testing;

Environmental monitoring;

Records review; and

Reanalysis;

Records that document the supply-chain program; and

Records that document applicable training for the preventive controls qualified individual and the qualified auditor.

The records that you must establish and maintain are subject to the requirements of subpart F of this part.

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§ 507.53 - Requirements applicable to a preventive controls qualified individual and a qualified auditor.
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§ 507.60 - Circumstances that may lead FDA to withdraw a qualified facility exemption.