TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
Subpart A - General Provisions
§ 117.1 - Applicability and status.
§ 117.3 - Definitions.
§ 117.4 - Qualifications of individuals who manufacture, process, pack, or hold food.
§ 117.5 - Exemptions.
§ 117.7 - Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.
§ 117.8 - Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.
§ 117.9 - Records required for this subpart.
Subpart B - Current Good Manufacturing Practice
§ 117.10 - Personnel.
§ 117.20 - Plant and grounds.
§ 117.35 - Sanitary operations.
§ 117.37 - Sanitary facilities and controls.
§ 117.40 - Equipment and utensils.
§ 117.80 - Processes and controls.
§ 117.93 - Warehousing and distribution.
§ 117.95 - Holding and distribution of human food by-products for use as animal food.
§ 117.110 - Defect action levels.
Subpart C - Hazard Analysis and Risk-Based Preventive Controls
§ 117.126 - Food safety plan.
§ 117.130 - Hazard analysis.
§ 117.135 - Preventive controls.
§ 117.136 - Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
§ 117.137 - Provision of assurances required under 117.136(a)(2), (3), and (4).
§ 117.139 - Recall plan.
§ 117.140 - Preventive control management components.
§ 117.145 - Monitoring.
§ 117.150 - Corrective actions and corrections.
§ 117.155 - Verification.
§ 117.160 - Validation.
§ 117.165 - Verification of implementation and effectiveness.
§ 117.170 - Reanalysis.
§ 117.180 - Requirements applicable to a preventive controls qualified individual and a qualified auditor.
§ 117.190 - Implementation records required for this subpart.
Subpart D - Modified Requirements
§ 117.201 - Modified requirements that apply to a qualified facility.
§ 117.206 - Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.
Subpart E - Withdrawal of a Qualified Facility Exemption
§ 117.251 - Circumstances that may lead FDA to withdraw a qualified facility exemption.
§ 117.254 - Issuance of an order to withdraw a qualified facility exemption.
§ 117.257 - Contents of an order to withdraw a qualified facility exemption.
§ 117.260 - Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
§ 117.264 - Procedure for submitting an appeal.
§ 117.267 - Procedure for requesting an informal hearing.
§ 117.270 - Requirements applicable to an informal hearing.
§ 117.274 - Presiding officer for an appeal and for an informal hearing.
§ 117.277 - Timeframe for issuing a decision on an appeal.
§ 117.280 - Revocation of an order to withdraw a qualified facility exemption.
§ 117.284 - Final agency action.
§ 117.287 - Reinstatement of a qualified facility exemption that was withdrawn.
Subpart F - Requirements Applying to Records That Must Be Established and Maintained
§ 117.301 - Records subject to the requirements of this subpart.
§ 117.305 - General requirements applying to records.
§ 117.310 - Additional requirements applying to the food safety plan.
§ 117.315 - Requirements for record retention.
§ 117.320 - Requirements for official review.
§ 117.325 - Public disclosure.
§ 117.330 - Use of existing records.
§ 117.335 - Special requirements applicable to a written assurance.
Subpart G - Supply-Chain Program
§ 117.405 - Requirement to establish and implement a supply-chain program.
§ 117.410 - General requirements applicable to a supply-chain program.
§ 117.415 - Responsibilities of the receiving facility.
§ 117.420 - Using approved suppliers.
§ 117.425 - Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
§ 117.430 - Conducting supplier verification activities for raw materials and other ingredients.
§ 117.435 - Onsite audit.
§ 117.475 - Records documenting the supply-chain program.
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