21 CFR 111.95
Under this subpart E, what records must you make and keep?
21 CFR 111.95 is the regulation titled “Under this subpart E, 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, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 111.70, in 8 letters
- Closed out
- 25% 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 111.95 most often, as written in the letters.
- 1 letterYou failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or…
- 1 letterYour batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260
The regulation
Read the text of 21 CFR 111.95 (eCFR, as of Sep 1, 2026)
(a) You must make and keep records required under this subpart E in accordance with subpart P of this part.
(b) Under this subpart E, you must make and keep the following records:
(1) The specifications established;
(2) Documentation of your qualification of a supplier for the purpose of relying on the supplier's certificate of analysis;
(3) Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and
(4) Documentation for why the results of appropriate tests or examinations for the product specifications selected under § 111.75(c)(1) ensure that the dietary supplement meets all product specifications;
(5) Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under § 111.75(d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under § 111.75 (c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.
(6) Documentation of FDA's response to a petition submitted under § 111.75(a)(1)(ii) providing for an exemption from the provisions of § 111.75(a)(1)(i).
[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.95.
- 21 CFR 111.70What specifications must you establish?8 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?8 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use8 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements6 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 101.9Nutrition labeling of food5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.95 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 STPCA Inc. dba Sun Ten Laboratoriesdietary supplements and unapproved drugsIssuedApr 7, 2023PostedAug 15, 2023
- DrugsView EarthLab, Inc., dba Wise Woman HerbalsGreen Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Healthy Prostate, Turmeric Gold Capsules, Upper Respiratory Support,…IssuedApr 27, 2023PostedMay 16, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.