21 CFR 111.315
What are the requirements for laboratory control processes?
21 CFR 111.315 is the regulation titled “What are the requirements for laboratory control processes?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 111.70, in 3 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 111.315 most often, as written in the letters.
- 1 letterYou failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for the use of criteria for selecting standard reference materials used in performing tests and…
The regulation
Read the text of 21 CFR 111.315 (eCFR, as of Sep 1, 2026)
You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:
(a) Use of criteria for establishing appropriate specifications;
(b) Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:
(1) Components, packaging, and labels;
(2) In-process materials;
(3) Finished batches of dietary supplements;
(4) Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and
(5) Packaged and labeled dietary supplements.
(c) Use of criteria for selecting appropriate examination and testing methods;
(d) Use of criteria for selecting standard reference materials used in performing tests and examinations; and
(e) Use of test methods and examinations in accordance with established criteria.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.315.
- 21 CFR 111.70What specifications must you establish?3 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?3 letters cite both
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?2 letters cite both
- 21 CFR 111.210What must the master manufacturing record include?2 letters cite both
- 21 CFR 111.260What must the batch record include?2 letters cite both
- 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?2 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use2 letters cite both
- 21 CFR 111.205What is the requirement to establish a master manufacturing record?1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 111.315 that FDA posted most recently.
- DrugsView Meta Labs Pharmaceuticals, LLCDietary supplements and unapproved drugs sold onlineIssuedMay 15, 2026PostedJun 2, 2026
- 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
- DrugsView MCACO, LTDdietary supplementsIssuedApr 21, 2022PostedMay 10, 2022
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