21 CFR 111.553
What are the requirements under this subpart O for written procedures?
21 CFR 111.553 is the regulation titled “What are the requirements under this subpart O 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 111.553 most often, as written in the letters.
- 1 letterYou failed to establish and follow written procedures for the requirements to review and investigate a product complaint, as required under 21 CFR 111.553. Specifically, our investigators requested your written…
- 1 letterYou failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you do not have written procedures for reviewing and…
The regulation
Read the text of 21 CFR 111.553 (eCFR, as of Sep 1, 2026)
You must establish and follow written procedures to fulfill the requirements of this subpart O.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.553.
- 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 101.93Certain types of statements for dietary supplements4 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?4 letters cite both
- 21 CFR 101.3Identity labeling of food in packaged form3 letters cite both
- 21 CFR 101.4Food; designation of ingredients3 letters cite both
- 21 CFR 111.25What are the requirements under this subpart D for written procedures?3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.553 that FDA posted most recently.
- 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
- DrugsView American Chinese Natural Herbs, Inc.dietary supplementsIssuedFeb 10, 2023PostedFeb 14, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.