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FEDERAL · 21 CFR

Part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

57 sections · Title 21: Food and Drugs

§ 507.1Applicability and status.
§ 507.3Definitions.
§ 507.4Qualifications of individuals who manufacture, process, pack, or hold animal food.
§ 507.5Exemptions.
§ 507.7Requirements that apply to a qualified facility.
§ 507.10Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
§ 507.12Applicability of this part to the holding and distribution of human food by-products for use as animal food.
§ 507.14Personnel.
§ 507.17Plant and grounds.
§ 507.19Sanitation.
§ 507.20Water supply and plumbing.
§ 507.22Equipment and utensils.
§ 507.25Plant operations.
§ 507.27Holding and distribution.
§ 507.28Holding and distribution of human food by-products for use as animal food.
§ 507.31Food safety plan.
§ 507.33Hazard analysis.
§ 507.34Preventive controls.
§ 507.36Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
§ 507.37Provision of assurances required under § 507.36(a)(2), (3), and (4).
§ 507.38Recall plan.
§ 507.39Preventive control management components.
§ 507.40Monitoring.
§ 507.42Corrective actions and corrections.
§ 507.45Verification.
§ 507.47Validation.
§ 507.49Verification of implementation and effectiveness.
§ 507.50Reanalysis.
§ 507.51Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.
§ 507.53Requirements applicable to a preventive controls qualified individual and a qualified auditor.
§ 507.55Implementation records required for this subpart.
§ 507.60Circumstances that may lead FDA to withdraw a qualified facility exemption.
§ 507.62Issuance of an order to withdraw a qualified facility exemption.
§ 507.65Contents of an order to withdraw a qualified facility exemption.
§ 507.67Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
§ 507.69Procedure for submitting an appeal.
§ 507.71Procedure for requesting an informal hearing.
§ 507.73Requirements applicable to an informal hearing.
§ 507.75Presiding officer for an appeal and for an informal hearing.
§ 507.77Timeframe for issuing a decision on an appeal.
§ 507.80Revocation of an order to withdraw a qualified facility exemption.
§ 507.83Final agency action.
§ 507.85Reinstatement of a qualified facility exemption that was withdrawn.
§ 507.105Requirement to establish and implement a supply-chain program.
§ 507.110General requirements applicable to a supply-chain program.
§ 507.115Responsibilities of the receiving facility.
§ 507.120Using approved suppliers.
§ 507.125Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
§ 507.130Conducting supplier verification activities for raw materials and other ingredients.
§ 507.135Onsite audit.
§ 507.175Records documenting the supply-chain program.
§ 507.200Records subject to the requirements of this subpart.
§ 507.202General requirements applying to records.
§ 507.206Additional requirements applying to the food safety plan.
§ 507.208Requirements for record retention.
§ 507.212Use of existing records.
§ 507.215Special requirements applicable to a written assurance.