CFR section

21 CFR 117.201(a)(2)(i): Modified requirements that apply to a qualified facility

PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD · Subpart D-Modified Requirements

Key facts

Citation 21 CFR 117.201(a)(2)(i)
Section Modified requirements that apply to a qualified facility
Part PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Subpart Subpart D-Modified Requirements
Subchapter 21 CFR B Food
Product types cited Food/Cosmetics
Regulation text (excerpt) (i) An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or

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