21 CFR 111.535
Under this subpart N, what records must you make and keep?
21 CFR 111.535 is the regulation titled “Under this subpart N, 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, 3 FDA warning letters have cited it.
- Letters citing it
- 3 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 3 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 111.535 most often, as written in the letters.
- 1 letterYou failed to establish and follow written procedures for returned dietary supplements for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.503. Specifically, you have no written procedures…
The regulation
Read the text of 21 CFR 111.535 (eCFR, as of Sep 1, 2026)
(a) You must make and keep records required under this subpart N in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this subpart N.
(2) Any material review and disposition decision on a returned dietary supplement;
(3) The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and,
(4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with § 111.70(e).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.535.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion3 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements3 letters cite both
- 21 CFR 101.9Nutrition labeling of food3 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?3 letters cite both
- 21 CFR 111.25What are the requirements under this subpart D for written procedures?3 letters cite both
- 21 CFR 111.35Under this subpart D, what records must you make and keep?3 letters cite both
- 21 CFR 111.453What are the requirements under this subpart for M written procedures?3 letters cite both
- 21 CFR 111.503What are the requirements under this subpart N for written procedures?3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.535 that FDA posted most recently.
- DrugsView Natural Relief Inc.Edema NatRelief 6 and BP NatRelief 11IssuedOct 18, 2023PostedNov 14, 2023
- DrugsView Osmosis, LLCOsmosis Skin Perfection Elixir, Sugar Detox Elixir, Elevate, Skin Clarifier, Recovery, Regenerate, Immune Defense ElixirIssuedAug 23, 2023PostedSep 5, 2023
- DrugsView Deggeh Foods, Inc.Actibest Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, Moringa Tea BagsIssuedJul 29, 2022PostedAug 16, 2022
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.