21 CFR 111.73
What is your responsibility for determining whether established specifications are met?
21 CFR 111.73 is the regulation titled “What is your responsibility for determining whether established specifications are met?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 111.70, in 6 letters
- Closed out
- 17% 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 111.73 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 letterYou failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and…
- 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 111.73 (eCFR, as of Sep 1, 2026)
You must determine whether the specifications you establish under § 111.70 are met.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.73.
- 21 CFR 111.70What specifications must you establish?6 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use6 letters cite both
- 21 CFR 111.260What must the batch record include?5 letters cite both
- 21 CFR 111.205What is the requirement to establish a master manufacturing record?4 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?4 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?4 letters cite both
- 21 CFR 111.95Under this subpart E, what records must you make and keep?4 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.73 that FDA posted most recently.
- DrugsView Imu-Tek Animal Health, IncorporatedColostrum-5 Capsules and Colostrum-5 PowderIssuedJun 5, 2026PostedJun 23, 2026
- DrugsView Mother Earth Minerals, Inc.Dietary supplements and mineral products (Calcium, Magnesium, Silver)IssuedMar 28, 2025PostedJun 3, 2025
- 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
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Counts include every citation in a letter, as the Letters filter does. How this database is built.