21 CFR § 117.110 - Defect action levels.

---
identifier: "/us/cfr/t21/s117.110"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 117.110 - Defect action levels."
title_number: 21
title_name: "Food and Drugs"
section_number: "117.110"
section_name: "Defect action levels."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "117"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 56145, Sept. 17, 2015, unless otherwise noted."
cfr_part: "117"
---


# 117.110 Defect action levels.

(a) The manufacturer, processor, packer, and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

(b) The mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food. For examples of defect action levels that may render food adulterated, see the Defect Levels Handbook, which is accessible at*http://www.fda.gov/pchfrule* and at*http://www.fda.gov*.