CFR section
21 CFR 107.50(e)(2): Terms and conditions
PART 107-INFANT FORMULA · Subpart C-Exempt Infant Formulas
Key facts
| Citation | 21 CFR 107.50(e)(2) |
|---|---|
| Section | Terms and conditions |
| Part | PART 107-INFANT FORMULA |
| Subpart | Subpart C-Exempt Infant Formulas |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (2) The manufacturer shall promptly notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of the Federal Food, Drug, and Cosmetic Act) that reasonably supports the conclusion that an exempt infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by paragraph (b) or (c) of this section, or when there is an exempt infant… |
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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.