21 CFR 211.111
Time limitations on production
21 CFR 211.111 is the regulation titled “Time limitations on production” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. 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 1271.10, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 211.111 (eCFR, as of Sep 1, 2026)
When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.111.
- 21 CFR 1271.10Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?1 letter cites both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?1 letter cites both
- 21 CFR 1271.290Tracking1 letter cites both
- 21 CFR 1271.3How does FDA define important terms in this part?1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.160General requirements1 letter cites both
- 21 CFR 211.166Stability testing1 letter cites both
Latest letters citing it
The letter citing 21 CFR 211.111 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.