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Defect Action Levels

The last subpart of 21 CFR I 10 covers natural or unavoidable defects in food for human use that present no health hazard. The FDA recognizes that defects can be present in foods produced under current good manufacturing practices (GMPs). The FDA has established maximum levels for these defects and uses them in deciding whether to recommend regulatory action. These FDA guidelines cannot be used as an excuse for not following the GMPs. Defect action levels are not listed in the CFR; however, subsection (e) in section 110. 110 provides information on how to obtain a current list.

Table 1. Sections of 21 CFR 110 with umbrella GMPS

Section Category
Subpart A-General Provisions
110.3 Definitions

110.5
Current good manufacturing practice
110.10 Personnel
110.19 Exclusions
Subpart B-Buildings and Facilities
110.20 Plant and grounds
110.35 Sanitary operations
110.37 Sanitary facilities and controls

Subpart C-Equipment

110.40 Equipment and utensils
Subpart E-Production and Process Controls
110.80 Processes and controls
110.93 Warehousing and distribution
Subpart G-Defect Action Levels
110.110Natural or unavoidable defects in food for human use that present no health hazard

Example: SOP 7: Automatic Labeling Machine>>





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