21 CFR 111.303
What are the requirements under this subpart J for written procedures?
21 CFR 111.303 is the regulation titled “What are the requirements under this subpart J for written procedures?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 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 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.303 (eCFR, as of Sep 1, 2026)
You must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.303.
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?1 letter cites both
- 21 CFR 111.315What are the requirements for laboratory control processes?1 letter cites both
- 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?1 letter cites both
- 21 CFR 111.70What specifications must you establish?1 letter cites both
- 21 CFR 111.75What must you do to determine whether specifications are met?1 letter cites both
- 21 CFR 111.77What must you do if established specifications are not met?1 letter cites both
- 21 CFR 111.95Under this subpart E, what records must you make and keep?1 letter cites both
- 21 CFR 201.5Drugs; adequate directions for use1 letter cites both
Latest letters citing it
The letter citing 21 CFR 111.303 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.