21 CFR 111.25
What are the requirements under this subpart D for written procedures?
21 CFR 111.25 is the regulation titled “What are the requirements under this subpart D for written procedures?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 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 4 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 111.25 most often, as written in the letters.
- 1 letterYou failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold…
The regulation
Read the text of 21 CFR 111.25 (eCFR, as of Sep 1, 2026)
You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for:
(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;
(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and
(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.25.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion4 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements4 letters cite both
- 21 CFR 101.9Nutrition labeling of food4 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?4 letters cite both
- 21 CFR 111.453What are the requirements under this subpart for M written procedures?4 letters cite both
- 21 CFR 111.503What are the requirements under this subpart N for written procedures?4 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use4 letters cite both
- 21 CFR 101.4Food; designation of ingredients3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.25 that FDA posted most recently.
- DrugsView Natural Relief Inc.Edema NatRelief 6 and BP NatRelief 11IssuedOct 18, 2023PostedNov 14, 2023
- DrugsView Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.dietary supplements and herbal productsIssuedAug 1, 2023PostedSep 19, 2023
- DrugsView Osmosis, LLCOsmosis Skin Perfection Elixir, Sugar Detox Elixir, Elevate, Skin Clarifier, Recovery, Regenerate, Immune Defense ElixirIssuedAug 23, 2023PostedSep 5, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.