CFR section
21 CFR 110.80(a)(4): Processes and controls
PART 110-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD · Subpart E-Production and Process Controls
Key facts
| Citation | 21 CFR 110.80(a)(4) |
|---|---|
| Section | Processes and controls |
| Part | PART 110-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD |
| Subpart | Subpart E-Production and Process Controls |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or… |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.