CFR section

21 CFR 110.80(a)(5): 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)(5)
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 Biologics, Drugs, Food/Cosmetics, General, Other_Regulations
Regulation text (excerpt) (5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.

At a glance

  • 100–999 Inspections citing this section
  • 10–99 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA