21 CFR Part 106: Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
Part 106 of title 21 runs to 27 sections across 7 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 27
- Subparts
- 7
- Words of regulation
- 16,175
- Current to
- 2026-09-10
Subpart A: General Provisions
Subpart B: Current Good Manufacturing Practice
- 106.5 Current good manufacturing practice2
- 106.6 Production and in-process control system9
- 106.10 Controls to prevent adulteration by workers5
- 106.20 Controls to prevent adulteration caused by facilities16
- 106.30 Controls to prevent adulteration caused by equipment or utensils24
- 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment11
- 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures19
- 106.50 Controls to prevent adulteration during manufacturing18
- 106.55 Controls to prevent adulteration from microorganisms5
- 106.60 Controls to prevent adulteration during packaging and labeling of infant formula7
- 106.70 Controls on the release of finished infant formula4
- 106.80 Traceability1
- 106.90 Audits of current good manufacturing practice2
Subpart C: Quality Control Procedures
Subpart D: Conduct of Audits
Subpart E: Quality Factors for Infant Formulas
Subpart F: Records and Reports
Subpart G: Registration, Submission, and Notification Requirements
- 106.110 New infant formula registration6
- 106.120 New infant formula submission18
- 106.121 Quality factor assurances for infant formulas20
- 106.130 Verification submission7
- 106.140 Submission concerning a change in infant formula that may adulterate the product7
- 106.150 Notification of an adulterated or misbranded infant formula4
- 106.160 Incorporation by reference19
Read 21 CFR part 106 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 106 cover?
- 21 CFR part 106 is Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. It runs to 27 sections across 7 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
Every section of part 106 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.