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- 21 CFR 110.20 · Plant and grounds.
- 21 CFR 110.35 · Sanitary operations.
- 21 CFR 110.37 · Sanitary facilities and controls.
- 21 CFR 110.40 · Equipment and utensils.
- 21 CFR 110.80 · Processes and controls.
- 21 CFR 110.93 · Warehousing and distribution.
- 21 CFR 110.110 · Natural or unavoidable defects in food for human use that present no health hazard.
- 21 CFR 111.1 · Who is subject to this part?
- 21 CFR 111.3 · What definitions apply to this part?
- 21 CFR 111.5 · Do other statutory provisions and regulations apply?
- 21 CFR 111.8 · What are the requirements under this subpart B for written procedures?
- 21 CFR 111.10 · What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?
- 21 CFR 111.12 · What personnel qualification requirements apply?
- 21 CFR 111.13 · What supervisor requirements apply?
- 21 CFR 111.14 · Under this subpart B, what records must you make and keep?
- 21 CFR 111.15 · What sanitation requirements apply to your physical plant and grounds?
- 21 CFR 111.16 · What are the requirements under this subpart C for written procedures?
- 21 CFR 111.20 · What design and construction requirements apply to your physical plant?
- 21 CFR 111.23 · Under this subpart C, what records must you make and keep?
- 21 CFR 111.25 · What are the requirements under this subpart D for written procedures?
- 21 CFR 111.27 · What requirements apply to the equipment and utensils that you use?
- 21 CFR 111.30 · What requirements apply to automated, mechanical, or electronic equipment?
- 21 CFR 111.35 · Under this subpart D, what records must you make and keep?
- 21 CFR 111.55 · What are the requirements to implement a production and process control system?
- 21 CFR 111.60 · What are the design requirements for the production and process control system?
- 21 CFR 111.65 · What are the requirements for quality control operations?
- 21 CFR 111.70 · What specifications must you establish?
- 21 CFR 111.73 · What is your responsibility for determining whether established specifications are met?
- 21 CFR 111.75 · What must you do to determine whether specifications are met?
- 21 CFR 111.77 · What must you do if established specifications are not met?
- 21 CFR 111.80 · What representative samples must you collect?
- 21 CFR 111.83 · What are the requirements for reserve samples?
- 21 CFR 111.87 · Who conducts a material review and makes a disposition decision?
- 21 CFR 111.90 · What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?
- 21 CFR 111.95 · Under this subpart E, what records must you make and keep?
- 21 CFR 111.103 · What are the requirements under this subpart F for written procedures?
- 21 CFR 111.105 · What must quality control personnel do?
- 21 CFR 111.110 · What quality control operations are required for laboratory operations associated with the production and process control system?
- 21 CFR 111.113 · What quality control operations are required for a material review and disposition decision?
- 21 CFR 111.117 · What quality control operations are required for equipment, instruments, and controls?
- 21 CFR 111.120 · What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
- 21 CFR 111.123 · What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
- 21 CFR 111.127 · What quality control operations are required for packaging and labeling operations?
- 21 CFR 111.130 · What quality control operations are required for returned dietary supplements?
- 21 CFR 111.135 · What quality control operations are required for product complaints?
- 21 CFR 111.140 · Under this subpart F, what records must you make and keep?
- 21 CFR 111.153 · What are the requirements under this subpart G for written procedures?
- 21 CFR 111.155 · What requirements apply to components of dietary supplements?
- 21 CFR 111.160 · What requirements apply to packaging and labels received?
- 21 CFR 111.165 · What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?
- 21 CFR 111.170 · What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?
- 21 CFR 111.180 · Under this subpart G, what records must you make and keep?
- 21 CFR 111.205 · What is the requirement to establish a master manufacturing record?
- 21 CFR 111.210 · What must the master manufacturing record include?
- 21 CFR 111.255 · What is the requirement to establish a batch production record?
- 21 CFR 111.260 · What must the batch record include?
- 21 CFR 111.303 · What are the requirements under this subpart J for written procedures?
- 21 CFR 111.310 · What are the requirements for the laboratory facilities that you use?
- 21 CFR 111.315 · What are the requirements for laboratory control processes?
- 21 CFR 111.320 · What requirements apply to laboratory methods for testing and examination?
- 21 CFR 111.325 · Under this subpart J, what records must you make and keep?
- 21 CFR 111.353 · What are the requirements under this subpart K for written procedures?
- 21 CFR 111.355 · What are the design requirements for manufacturing operations?
- 21 CFR 111.360 · What are the requirements for sanitation?
- 21 CFR 111.365 · What precautions must you take to prevent contamination?
- 21 CFR 111.370 · What requirements apply to rejected dietary supplements?
- 21 CFR 111.375 · Under this subpart K, what records must you make and keep?
- 21 CFR 111.403 · What are the requirements under this subpart L for written procedures?
- 21 CFR 111.410 · What requirements apply to packaging and labels?
- 21 CFR 111.415 · What requirements apply to filling, assembling, packaging, labeling, and related operations?
- 21 CFR 111.420 · What requirements apply to repackaging and relabeling?
- 21 CFR 111.425 · What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
- 21 CFR 111.430 · Under this subpart L, what records must you make and keep?
- 21 CFR 111.453 · What are the requirements under this subpart for M written procedures?
- 21 CFR 111.455 · What requirements apply to holding components, dietary supplements, packaging, and labels?
- 21 CFR 111.460 · What requirements apply to holding in-process material?
- 21 CFR 111.465 · What requirements apply to holding reserve samples of dietary supplements?
- 21 CFR 111.470 · What requirements apply to distributing dietary supplements?
- 21 CFR 111.475 · Under this subpart M, what records must you make and keep?
- 21 CFR 111.503 · What are the requirements under this subpart N for written procedures?
- 21 CFR 111.510 · What requirements apply when a returned dietary supplement is received?
- 21 CFR 111.515 · When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
- 21 CFR 111.520 · When may a returned dietary supplement be salvaged?
- 21 CFR 111.525 · What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
- 21 CFR 111.530 · When must an investigation be conducted of your manufacturing processes and other batches?
- 21 CFR 111.535 · Under this subpart N, what records must you make and keep?
- 21 CFR 111.553 · What are the requirements under this subpart O for written procedures?
- 21 CFR 111.560 · What requirements apply to the review and investigation of a product complaint?
- 21 CFR 111.570 · Under this subpart O, what records must you make and keep?
- 21 CFR 111.605 · What requirements apply to the records that you make and keep?
- 21 CFR 111.610 · What records must be made available to FDA?
- 21 CFR 112.1 · What food is covered by this part?
- 21 CFR 112.2 · What produce is not covered by this part?
- 21 CFR 112.3 · What definitions apply to this part?
- 21 CFR 112.4 · Which farms are subject to the requirements of this part?
- 21 CFR 112.5 · Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?
- 21 CFR 112.6 · What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?
- 21 CFR 112.7 · What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?
- 21 CFR 112.11 · What general requirements apply to persons who are subject to this part?
- 21 CFR 112.12 · Are there any alternatives to the requirements established in this part?