CFR section

21 CFR 120.25(d): Process verification for certain processors

PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS · Subpart B-Pathogen Reduction

Key facts

Citation 21 CFR 120.25(d)
Section Process verification for certain processors
Part PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
Subpart Subpart B-Pathogen Reduction
Subchapter 21 CFR B Food
Product types cited Food/Cosmetics
Regulation text (excerpt) (d) If either 10 mL subsample is positive for E. coli, the 20 mL sample is recorded as positive and the processor shall: (1) Review monitoring records for the control measures to attain the 5-log reduction standard and correct those conditions and practices that are not met. In addition, the processor may choose to test the sample for the presence of pathogens of concern. (2) If the review of monitoring records or the additional testing indicates that the 5-log reduction standard was not…

At a glance

  • 1–9 Inspections citing this section
  • None 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