§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.
Editorial Note: Nomenclature changes to part 117 appear at 81 FR 49896, July 29, 2016.