21 CFR Part 507
PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
- PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter E—Animal Drugs, Feeds, and Related Products
- Subpart A—General Provisions
- § 507.1 Applicability and status.
- § 507.3 Definitions.
- § 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
- § 507.5 Exemptions.
- § 507.7 Requirements that apply to a qualified facility.
- § 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
- § 507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food.
- Subpart B—Current Good Manufacturing Practice
- § 507.14 Personnel.
- § 507.17 Plant and grounds.
- § 507.19 Sanitation.
- § 507.20 Water supply and plumbing.
- § 507.22 Equipment and utensils.
- § 507.25 Plant operations.
- § 507.27 Holding and distribution.
- § 507.28 Holding and distribution of human food by-products for use as animal food.
- Subpart C—Hazard Analysis and Risk-Based Preventive Controls
- § 507.31 Food safety plan.
- § 507.33 Hazard analysis.
- § 507.34 Preventive controls.
- § 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
- § 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4).
- § 507.38 Recall plan.
- § 507.39 Preventive control management components.
- § 507.40 Monitoring.
- § 507.42 Corrective actions and corrections.
- § 507.45 Verification.
- § 507.47 Validation.
- § 507.49 Verification of implementation and effectiveness.
- § 507.50 Reanalysis.
- § 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.
- § 507.53 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
- § 507.55 Implementation records required for this subpart.
- Subpart D—Withdrawal of a Qualified Facility Exemption
- § 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption.
- § 507.62 Issuance of an order to withdraw a qualified facility exemption.
- § 507.65 Contents of an order to withdraw a qualified facility exemption.
- § 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
- § 507.69 Procedure for submitting an appeal.
- § 507.71 Procedure for requesting an informal hearing.
- § 507.73 Requirements applicable to an informal hearing.
- § 507.75 Presiding officer for an appeal and for an informal hearing.
- § 507.77 Timeframe for issuing a decision on an appeal.
- § 507.80 Revocation of an order to withdraw a qualified facility exemption.
- § 507.83 Final agency action.
- § 507.85 Reinstatement of a qualified facility exemption that was withdrawn.
- Subpart E—Supply-Chain Program
- § 507.105 Requirement to establish and implement a supply-chain program.
- § 507.110 General requirements applicable to a supply-chain program.
- § 507.115 Responsibilities of the receiving facility.
- § 507.120 Using approved suppliers.
- § 507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
- § 507.130 Conducting supplier verification activities for raw materials and other ingredients.
- § 507.135 Onsite audit.
- § 507.175 Records documenting the supply-chain program.
- Subpart F—Requirements Applying to Records That Must Be Established and Maintained
- § 507.200 Records subject to the requirements of this subpart.
- § 507.202 General requirements applying to records.
- § 507.206 Additional requirements applying to the food safety plan.
- § 507.208 Requirements for record retention.
- § 507.212 Use of existing records.
- § 507.215 Special requirements applicable to a written assurance.
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