21 CFR 111.103
What are the requirements under this subpart F for written procedures?
21 CFR 111.103 is the regulation titled “What are the requirements under this subpart F for written procedures?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 101.36, in 7 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 111.103 most often, as written in the letters.
- 1 letterYou failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for…
- 1 letterYou failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for…
- 1 letterYour firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision as…
The regulation
Read the text of 21 CFR 111.103 (eCFR, as of Sep 1, 2026)
You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.103.
- 21 CFR 101.36Nutrition labeling of dietary supplements7 letters cite both
- 21 CFR 101.9Nutrition labeling of food7 letters cite both
- 21 CFR 111.70What specifications must you establish?7 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use7 letters cite both
- 21 CFR 101.4Food; designation of ingredients6 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?6 letters cite both
- 21 CFR 111.260What must the batch record include?6 letters cite both
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.103 that FDA posted most recently.
- DrugsView Mericon Industries, Inc.Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 CapsulesIssuedJul 17, 2025PostedSep 16, 2025
- DrugsView Mother Earth Minerals, Inc.Dietary supplements and mineral products (Calcium, Magnesium, Silver)IssuedMar 28, 2025PostedJun 3, 2025
- DrugsView Natural Relief Inc.Edema NatRelief 6 and BP NatRelief 11IssuedOct 18, 2023PostedNov 14, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.