CFR section

21 CFR 117.110(b): Defect action levels

PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD · Subpart B-Current Good Manufacturing Practice

Key facts

Citation 21 CFR 117.110(b)
Section Defect action levels
Part PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Subpart Subpart B-Current Good Manufacturing Practice
Subchapter 21 CFR B Food
Product types cited Food/Cosmetics
Regulation text (excerpt) (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.

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