21 CFR 111.55
What are the requirements to implement a production and process control system?
21 CFR 111.55 is the regulation titled “What are the requirements to implement a production and process control system?” 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 101.36, 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.
- 02021
- 22022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.55 (eCFR, as of Sep 1, 2026)
You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.55.
- 21 CFR 101.36Nutrition labeling of dietary supplements2 letters cite both
- 21 CFR 101.4Food; designation of ingredients2 letters cite both
- 21 CFR 101.9Nutrition labeling of food2 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?2 letters cite both
- 21 CFR 111.105What must quality control personnel do?2 letters cite both
- 21 CFR 111.127What quality control operations are required for packaging and labeling operations?2 letters cite both
- 21 CFR 111.70What specifications must you establish?2 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use2 letters cite both
Latest letters citing it
The 2 letters citing 21 CFR 111.55 that FDA posted most recently.
- DrugsView Deggeh Foods, Inc.Actibest Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, Moringa Tea BagsIssuedJul 29, 2022PostedAug 16, 2022
- DrugsView C R Supplements, LLCCalcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost PackIssuedApr 20, 2022PostedMay 3, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.