21 CFR 211.111
Time limitations on production.
- Inspections citing it: 210
- Of those classified, ended OAI: 35%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Nov 6, 2026When 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.
Recently Cited Sites
Newest inspections citing this section; each opens the site- Tender Corporation D/B/A Adventure Ready BrandsUnited States · Apr 10, 2026
- Westwood Laboratories, LLC.United States · Mar 26, 2026
- Tarmac Products, Inc.United States · Feb 6, 2026
- Innocore Sales & Marketing Inc.Canada · Apr 25, 2025
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR