21 CFR 11.260
21 CFR 11.260 is the regulation in 21 CFR Part 11, Electronic Records; Electronic Signatures. 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 101.12, in 1 letter
- Closed out
- 100% 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
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 11.260.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion1 letter cites both
- 21 CFR 101.36Nutrition labeling of dietary supplements1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.9Nutrition labeling of food1 letter cites both
- 21 CFR 111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?1 letter cites both
- 21 CFR 111.210What must the master manufacturing record include?1 letter cites both
- 21 CFR 111.255What is the requirement to establish a batch production record?1 letter cites both
- 21 CFR 111.260What must the batch record include?1 letter cites both
Latest letters citing it
The letter citing 21 CFR 11.260 that FDA posted most recently.
See the letter citing 21 CFR 11.260 →Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.