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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 117.110: Defect action levels.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
  4. PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
  5. Subpart B—Current Good Manufacturing Practice

(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 athttp://www.fda.gov/pchfrule and athttp://www.fda.gov.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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