21 CFR 111.560
What requirements apply to the review and investigation of a product complaint?
21 CFR 111.560 is the regulation titled “What requirements apply to the review and investigation of a product complaint?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 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 2 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.
- 02021
- 02022
- 22023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 111.560 most often, as written in the letters.
- 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 111.560 (eCFR, as of Sep 1, 2026)
(a) A qualified person must:
(1) Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and
(2) Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.
(b) Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed.
(c) The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and followup action of any investigation performed, must extend to all relevant batches and records.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.560.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion2 letters cite both
- 21 CFR 101.3Identity labeling of food in packaged form2 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements2 letters cite both
- 21 CFR 101.9Nutrition labeling of food2 letters cite both
- 21 CFR 101.93Certain types of statements for dietary supplements2 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?2 letters cite both
- 21 CFR 111.553What are the requirements under this subpart O for written procedures?2 letters cite both
- 21 CFR 101.15Food; prominence of required statements1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 111.560 that FDA posted most recently.
- 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.