21 CFR 111.83
What are the requirements for reserve samples?
21 CFR 111.83 is the regulation titled “What are the requirements for reserve samples?” 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 1 on the same dates in 2025
- Most often cited with
- 21 CFR 111.255, in 2 letters
- Closed out
- 50% 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 111.83 most often, as written in the letters.
- 1 letterYou failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83. Specifically, during the inspection, your management stated that…
- 1 letterYou failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a)
The regulation
Read the text of 21 CFR 111.83 (eCFR, as of Sep 1, 2026)
(a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute.
(b) The reserve samples must:
(1) Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere;
(2) Be identified with the batch, lot, or control number;
(3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and
(4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.83.
- 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
- 21 CFR 201.5Drugs; adequate directions for use2 letters cite both
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion1 letter cites both
- 21 CFR 101.36Nutrition labeling of dietary supplements1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.9Nutrition labeling of food1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 111.83 that FDA posted most recently.
- DrugsView Mother Earth Minerals, Inc.Dietary supplements and mineral products (Calcium, Magnesium, Silver)IssuedMar 28, 2025PostedJun 3, 2025
- DrugsView Herbal Vitality, Inc.Unapproved drugs and dietary supplementsIssuedMar 7, 2023PostedMar 21, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.