21 CFR 111.140
Under this subpart F, what records must you make and keep?
21 CFR 111.140 is the regulation titled “Under this subpart F, 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, 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 101.36, 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.
The regulation
Read the text of 21 CFR 111.140 (eCFR, as of Sep 1, 2026)
(a) You must make and keep the records required under this subpart F in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing;
(2) Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the following:
(i) Date that the review, approval, or rejection was performed; and
(ii) Signature of the person performing the review, approval, or rejection; and
(3) Documentation of any material review and disposition decision and followup. Such documentation must be included in the appropriate batch production record and must include:
(i) Identification of the specific deviation or the unanticipated occurrence;
(ii) Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence;
(iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement or a failure to package and label the dietary supplement as specified in the master manufacturing record;
(iv) Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence;
(v) Explanation of what you did with the component, dietary supplement, packaging, or label;
(vi) A scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected; and
(vii) The signature of the individual(s) designated to perform the quality control operation, who conducted the material review and made the disposition decision, and of each qualified individual who provides information relevant to that material review and disposition decision.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.140.
- 21 CFR 101.36Nutrition labeling of dietary supplements2 letters cite both
- 21 CFR 101.4Food; designation of ingredients2 letters cite both
- 21 CFR 101.9Nutrition labeling of food2 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?2 letters cite both
- 21 CFR 111.205What is the requirement to establish a master manufacturing record?2 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?2 letters cite both
- 21 CFR 111.260What must the batch record include?2 letters cite both
- 21 CFR 111.70What specifications must you establish?2 letters cite both
Latest letters citing it
The 2 letters citing 21 CFR 111.140 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 C R Supplements, LLCCalcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost PackIssuedApr 20, 2022PostedMay 3, 2022
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