21 CFR 117.110 - Defect Action Levels

What it says

FDA establishes maximum levels of natural or unavoidable defects in food for human use that present no health hazard, known as defect action levels. The existence of a defect action level does not excuse a firm from complying with the requirement to produce food under CGMP, and food must not contain defects at levels that are avoidable by good manufacturing practice. Firms must not blend food containing defects above the action level with other food.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A defect action level is a limit for unavoidable defects, such as insect fragments or mold, not a permission to produce food with them.
• Blending adulterated food with clean food to bring it below the level is not allowed.
• Raw material controls and sanitation reduce defects before they become a regulatory problem.

What FDA inspectors look for

• Whether food contains defects above applicable action levels.
• Whether defects result from avoidable conditions such as poor sanitation.
• Whether any blending of defective lots is taking place.

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