CFR section
21 CFR 117.201(a): 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) |
|---|---|
| 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) | (a) Attestations to be submitted. A qualified facility must submit the following attestations to FDA: (1) An attestation that the facility is a qualified facility as defined in § 117.3. For the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011; and (2) (i) An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive… |
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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.