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Part 117
FEDERAL · 21 CFR
Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
61 sections · Title 21: Food and Drugs
§ 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.