CFR section
21 CFR 106.100(e)(3): Records
PART 106-INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS · Subpart F-Records and Reports
Key facts
| Citation | 21 CFR 106.100(e)(3) |
|---|---|
| Section | Records |
| Part | PART 106-INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS |
| Subpart | Subpart F-Records and Reports |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (3) Documentation, in accordance with § 106.6(c), of the monitoring at any point, step, or stage in the manufacturer 's production process where control is deemed necessary to prevent adulteration. These records shall include: (i) A list of the specifications established at each point, step, or stage in the production process where control is deemed necessary to prevent adulteration, in accordance with § 106.6(c)(1), including documentation of the scientific basis for each specification; (ii)… |
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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.