CFR section
21 CFR 117.190(a): Implementation records required for this subpart
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 117.190(a) |
|---|---|
| Section | Implementation records required for this subpart |
| 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 |
| Regulation text (excerpt) | (a) You must establish and maintain the following records documenting implementation of the food safety plan: (1) Documentation, as required by § 117.136(b), of the basis for not establishing a preventive control in accordance with § 117.136(a); (2) Records that document the monitoring of preventive controls; (3) Records that document corrective actions; (4) Records that document verification, including, as applicable, those related to: (i) Validation; (ii) Verification of monitoring; (iii)… |
At a glance
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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.