21 CFR 111.23
Under this subpart C, what records must you make and keep?
21 CFR 111.23 is the regulation titled “Under this subpart C, what records must you make and keep?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.12, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.23 (eCFR, as of Sep 1, 2026)
(a) You must make and keep records required under this subpart C in accordance with subpart P of this part.
(b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control.
(c) You must make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of § 111.15(e)(2).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.23.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion1 letter cites both
- 21 CFR 101.13Nutrient content claims, general principles1 letter cites both
- 21 CFR 101.15Food; prominence of required statements1 letter cites both
- 21 CFR 101.2Information panel of package form food1 letter cites both
- 21 CFR 101.3Identity labeling of food in packaged form1 letter cites both
- 21 CFR 101.36Nutrition labeling of dietary supplements1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributor1 letter cites both
Latest letters citing it
The letter citing 21 CFR 111.23 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.