CFR section
21 CFR 117.136(a)(2): Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control
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 117.136(a)(2) |
|---|---|
| Section | Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control |
| 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) | (2) You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in this subpart to ensure that the identified hazard will be significantly minimized or prevented and you: (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance, subject to the requirements of § 117.137, that the… |
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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.