21 CFR 111.320
What requirements apply to laboratory methods for testing and examination?
21 CFR 111.320 is the regulation titled “What requirements apply to laboratory methods for testing and examination?” 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 111.113, 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 111.320 (eCFR, as of Sep 1, 2026)
(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.320.
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?2 letters cite both
- 21 CFR 111.315What are the requirements for laboratory control processes?2 letters cite both
- 21 CFR 111.70What specifications must you establish?2 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?2 letters cite both
- 21 CFR 111.210What must the master manufacturing record include?1 letter cites both
- 21 CFR 111.260What must the batch record include?1 letter cites both
- 21 CFR 111.303What are the requirements under this subpart J for written procedures?1 letter cites both
- 21 CFR 111.77What must you do if established specifications are not met?1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 111.320 that FDA posted most recently.
- 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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Counts include every citation in a letter, as the Letters filter does. How this database is built.