CFR section

21 CFR 117.145(b): Monitoring

PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD · Subpart C-Hazard Analysis and Risk-Based Preventive Controls

Key facts

Citation 21 CFR 117.145(b)
Section Monitoring
Part PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Subpart Subpart C-Hazard Analysis and Risk-Based Preventive Controls
Subchapter 21 CFR B Food
Product types cited Food/Cosmetics, General
Regulation text (excerpt) (b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

At a glance

  • 10–99 Inspections citing this section
  • 1–9 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