21 CFR Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Part 111 of title 21 runs to 84 sections across 16 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 84
- Subparts
- 16
- Words of regulation
- 14,182
- Current to
- 2026-09-10
What this clause controls in practice
A food safety plan controls one hazard under 21 CFR part 111, and FDA food recalls name an unapproved ingredient in 536 enforcement records since 2012. That is where the clause belongs, not a finding against any firm named below: a recall record states a reason, and most FDA food recalls are initiated by the firm itself.
Recent records naming one of those hazards:
Subpart A: General Provisions
Subpart B: Personnel
- 111.8 What are the requirements under this subpart B for written procedures?1
- 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?15
- 111.12 What personnel qualification requirements apply?3
- 111.13 What supervisor requirements apply?2
- 111.14 Under this subpart B, what records must you make and keep?4
Subpart C: Physical Plant and Grounds
- 111.15 What sanitation requirements apply to your physical plant and grounds?35
- 111.16 What are the requirements under this subpart C for written procedures?1
- 111.20 What design and construction requirements apply to your physical plant?30
- 111.23 Under this subpart C, what records must you make and keep?3
Subpart D: Equipment and Utensils
- 111.25 What are the requirements under this subpart D for written procedures?4
- 111.27 What requirements apply to the equipment and utensils that you use?45
- 111.30 What requirements apply to automated, mechanical, or electronic equipment?6
- 111.35 Under this subpart D, what records must you make and keep?20
Subpart E: Requirement to Establish a Production and Process Control System
- 111.55 What are the requirements to implement a production and process control system?1
- 111.60 What are the design requirements for the production and process control system?2
- 111.65 What are the requirements for quality control operations?1
- 111.70 What specifications must you establish?13
- 111.73 What is your responsibility for determining whether established specifications are met?1
- 111.75 What must you do to determine whether specifications are met?33
- 111.77 What must you do if established specifications are not met?3
- 111.80 What representative samples must you collect?6
- 111.83 What are the requirements for reserve samples?6
- 111.87 Who conducts a material review and makes a disposition decision?1
- 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?7
- 111.95 Under this subpart E, what records must you make and keep?8
Subpart F: Production and Process Control System: Requirements for Quality Control
- 111.103 What are the requirements under this subpart F for written procedures?1
- 111.105 What must quality control personnel do?10
- 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?4
- 111.113 What quality control operations are required for a material review and disposition decision?9
- 111.117 What quality control operations are required for equipment, instruments, and controls?5
- 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?6
- 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?14
- 111.127 What quality control operations are required for packaging and labeling operations?9
- 111.130 What quality control operations are required for returned dietary supplements?7
- 111.135 What quality control operations are required for product complaints?1
- 111.140 Under this subpart F, what records must you make and keep?14
Subpart G: Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
- 111.153 What are the requirements under this subpart G for written procedures?1
- 111.155 What requirements apply to components of dietary supplements?9
- 111.160 What requirements apply to packaging and labels received?9
- 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)?9
- 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?1
- 111.180 Under this subpart G, what records must you make and keep?11
Subpart H: Production and Process Control System: Requirements for the Master Manufacturing Record
Subpart I: Production and Process Control System: Requirements for the Batch Production Record
Subpart J: Production and Process Control System: Requirements for Laboratory Operations
- 111.303 What are the requirements under this subpart J for written procedures?1
- 111.310 What are the requirements for the laboratory facilities that you use?4
- 111.315 What are the requirements for laboratory control processes?11
- 111.320 What requirements apply to laboratory methods for testing and examination?2
- 111.325 Under this subpart J, what records must you make and keep?6
Subpart K: Production and Process Control System: Requirements for Manufacturing Operations
- 111.353 What are the requirements under this subpart K for written procedures?1
- 111.355 What are the design requirements for manufacturing operations?1
- 111.360 What are the requirements for sanitation?1
- 111.365 What precautions must you take to prevent contamination?19
- 111.370 What requirements apply to rejected dietary supplements?1
- 111.375 Under this subpart K, what records must you make and keep?2
Subpart L: Production and Process Control System: Requirements for Packaging and Labeling Operations
- 111.403 What are the requirements under this subpart L for written procedures?1
- 111.410 What requirements apply to packaging and labels?4
- 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?11
- 111.420 What requirements apply to repackaging and relabeling?3
- 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?1
- 111.430 Under this subpart L, what records must you make and keep?2
Subpart M: Holding and Distributing
- 111.453 What are the requirements under this subpart for M written procedures?1
- 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?3
- 111.460 What requirements apply to holding in-process material?2
- 111.465 What requirements apply to holding reserve samples of dietary supplements?4
- 111.470 What requirements apply to distributing dietary supplements?1
- 111.475 Under this subpart M, what records must you make and keep?4
Subpart N: Returned Dietary Supplements
- 111.503 What are the requirements under this subpart N for written procedures?1
- 111.510 What requirements apply when a returned dietary supplement is received?1
- 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?3
- 111.520 When may a returned dietary supplement be salvaged?1
- 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?2
- 111.530 When must an investigation be conducted of your manufacturing processes and other batches?1
- 111.535 Under this subpart N, what records must you make and keep?6
Subpart O: Product Complaints
Subpart P: Records and Recordkeeping
Read 21 CFR part 111 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 111 cover?
- 21 CFR part 111 is Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. It runs to 84 sections across 16 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
- Which hazards does 21 CFR part 111 control?
- A food safety plan controls an unapproved ingredient under part 111. Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
Every section of part 111 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.