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.